Quality Assurance Manager jobs at Sanofi US

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Quality Control Manager to join our talented team at our office located in Cary, North Carolina. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance (QA/QC) program for ongoing Construction Projects. This is a leadership role responsible for working with the On-Site Construction Management Team to ensure the established project standards are followed. Additional Responsibilities Develops, plans, manages, and administers the implementation of project-specific Construction QA/QC Plans with the CM team, contractors, and clients. Trains the project team on their criteria and implementation. Develops special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC project-specific plans. Reports and publish quality reports, audits, and initiatives to the Project Manager and review with the project team prior to publication. Ensures Corporate Quality initiatives and goals are achieved. Develops a system to compile, monitor, track, and confirm deficiencies and successes of work performed by direct-hire and subcontract work crews. Evaluates testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. Reviews utility matrices developed to start up and commission systems and skids. Directs the tracking of deficiencies, test results, or other regularly reported quality control data. Manages non-conformance reporting activities and tracks efficiencies from identification through resolution. Monitors performance of quality control systems to ensure effectiveness and efficiency. Verifies that the construction of systems and equipment are installed in accordance with approved construction documents. Reviews plans and specifications to ensure requirements are met for each construction process. Understand and apply federal, state, and local codes, policies, laws, and regulations. Identifies quality problems or areas for improvement and recommends solutions. Assists in performing system walk downs/final inspections; closeout and startup; establishes system completion punch list items; and, ensures all deficiencies are corrected. Attends pre-construction and construction meetings noting areas/topics that may present future problems/risks and present to the project manager for consultation. Implements the corporate safety culture and principles into the QA/QC programs. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights! Qualifications & Requirements B.S. in a Science, Engineering, Construction management, or related field. Quality Assurance and Quality Control Management training and experience with 15 years of field experience in construction and/or engineering. Strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry along with the ability to interpret complex issues and provide recommended courses of action. Proficient skill level in Microsoft Office Suite. Preferred Qualifications First Aid/CPR training. Primavera P6 and MS Project knowledge. Commissioning and System startup experience. Safety You will travel 50% of the time, or as necessary to complete duties. You may be assigned to a client for an extended period of time (1-2 years). OSHA 10 certification (IPS will provide tools) must be maintained during employment. Overnight travel is possible. You will focus on construction field activity and office time will be limited. You will visit Client sites and will be required to adhere to stated safety rules. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

GxP Quality Auditor / Senior Quality Lead Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity. Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment. Key Responsibilities Coordinate between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements Develop and defend bracketing justification for multiple manufacturing lines and isolators Facilitate governance meetings, escalate risks, and report status to leadership Review and approve protocol templates, summaries, and reports for finalization Qualifications Bachelor's degree in a scientific or industry-related field Minimum 7+ years of experience in pharmaceutical manufacturing or compliance Proven experience developing bracketing and matrixing strategies Strong knowledge of FDA, EMA, and HMRA regulations Familiarity with cGMP and facility/equipment validation requirements Excellent technical writing and communication skills Ability to work full-time on-site in Greenville, NC Why Join This Team? Competitive compensation and performance-based incentives Comprehensive benefits package including medical, dental, vision, and retirement plans Paid time off, holidays, and professional development opportunities Collaborative culture with strong career growth potential

STAQ is currently hiring for a Quality Control Manager in the Denver area Monday to Friday, 8 AM to 5 PM Salary: $105K-$110K/year STAQ Pharma is a 503B Outsourcing Facility located in Denver. STAQ Pharma produces sterile injectable medications for adults and pediatric patients, compounded under cGMP standards. STAQ's ownership and board are composed of large hospital systems ensuring the priority focus remains on delivering needed medications in a safe and timely manner. We are looking for exception people to join the STAQ team. This role is responsible for leading all Quality Control (QC) activities at the site. The QC Manager will encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives. Roles and Responsibilities Establish an environmental monitoring program for the facility utilizing a risk-based approach to new and existing procedures. Develop, manage, and improve QC processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B). Prepare, review, manage, and approve controlled documents (SOPs, protocols, logbooks, reports, etc.) relevant to STAQ QC operations. Lead and draft investigations/deviations/change controls/OOS/CAPAs as they relate to environmental monitoring or Quality Control deviations. Provide expertise and support to the Operations, Regulatory, and Quality teams. Subject matter expert during audits or inspections as it relates to microbiology/environmental monitoring. Recruit, retain, and mentor direct reports to comprise the QC team. Promote personal and professional growth of team members. Support the batch disposition process including management of reserve samples and QC samples for batch release testing. Manage the budget for the QC Lab department to meet financial objectives. Lead the Stability Program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc. Collect, submit, ship, and manage appropriate raw material, microbiological and finished goods samples to third party testing laboratories. Coordinate and facilitate operations within the internal laboratory to ensure Environmental Monitoring samples are performed, tested, reviewed, and trended appropriately. Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. Analyze and interpret trends and identify opportunities to improve processes and achieve state of control. Focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up, and ability to make timely and sound decisions. Implement methods of continuous improvement in daily work and in evaluation of company processes and performance. Other duties as assigned. Preferred Qualifications and Education B.S. or B.A. in Microbiology or a closely related field / or equivalent experience. Minimum five (5) years' experience in a quality control environment. Experience in a cGMP pharmaceutical/aseptic manufacturing environment. Must demonstrate understanding and/or working knowledge of regulations/guidelines such as FDA, USP, ICH, etc. Proficiency/experience with environmental monitoring program for aseptic manufacturing facility, including personnel monitoring, and qualification program. Preferred Experience and Skills Working knowledge of aseptic/sterile manufacturing techniques. Ability to coordinate multiple priorities in a fast-paced environment. Strong communication skills with the ability to interact with all levels across the organization. Demonstrated excellent interpersonal skills and flexibility. Familiarity with 21 CFR Part 11/210/211. Additional Notes Join a dynamic team at the leading edge as we build out a new 137K sq. ft. manufacturing facility. This position will work closely with cross functional teams and report quality data to the department heads for each team, as needed Timeline: We will be accepting applications on an ongoing basis until position is filled.

The Global Quality Large Molecule Analytical Sciences (GQLMAS) team is responsible for the establishment and performance of commercial large molecule analytical techniques, including method development, validation, troubleshooting, transfers as well as stocking and supplying critical reagents to global laboratories. We collaborate with both internal teams and outsourced partners. Our team is fast paced, highly motivated, and focused on advancing our Company's large molecule pipeline as well as supporting growth and performance of existing licensed products. Specific job responsibilities could include analytical method development, troubleshooting, validation, sample testing supporting process development/changes, and logistical support for sample management and shipments, all while providing hands-on experience in a GMP environment. Interested candidates should have the following Experience with pipettes, balances, pH meters, biosafety cabinets, and/or fume hoods. Experience with documenting experimentations including objectives, reagents, procedure, results, and conclusions. Experience in one or more of the following analytical laboratory techniques: Cell culture techniques: mammalian cell culture, cell-based assays, virus plaque, virus TCID50, Attribute testing: ELISA, BCA, Bradford, UPLC/HPLC, cIEF, CE, LC-MS, UV-Vis, DLS, MALS/RI, CCIT, ICP-MS Microbial techniques: kinetic turbidimetric/chromogenic, sterility, environmental monitoring, microbial limits testing Or interest in learning logistics of Good Manufacturing Practices (GMP) sample movement. Ability to work independently and within a cross-functional teams. Ability to learn new techniques. Good technical, communication (oral and written), interpersonal, and teamwork skills. Required Education and Experience: Candidates must be currently working toward B.S. in Biology, Biochemistry, Chemistry, Logistics or a related field. Education Minimum Requirement: Minimum of three (3) years in a BS -OR- in a MS program in one of the following disciplines: Biology Biochemistry Chemistry Molecular Biology Virology Logistics Candidates must be successful candidates will possess strong interpersonal and writing skills, with attention to detail and the ability to work independently. Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Salary range: The salary range for this role is $39,600.00-$105,500.00 USD MD2026 FTP2026 Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Required Skills: Assay, Assay, Biochemistry, Business, Cell-Based Assays, Cell Cultures, Clinical Research, Cloud Data Catalog, Communication, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Event Planning, GMP Compliance, Immunochemistry, Key Performance Indicators (KPI), Laboratory Techniques, Mammalian Cell, Mammalian Cell Culture, Molecular Biology, Production Process Development {+ 5 more} Preferred Skills: Job Posting End Date: 11/3/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL Summit Summit Therapeutics Inc is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC HARMONi Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who were previously treated with a 3rd generation EGFR TKI HARMONi 3 Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLC HARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC Colorectal Cancer CRC HARMONi GI3 Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role The Manager Clinical QA will collaborate closely with Regulatory Affairs QA R&D and other cross functional teams within the Company to provide GCPGLPGPV and compliance related advice to internal clinical study teams This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary taking the lead in ensuring project related procedural documents comply to relevant GxPs and regulatory requirements and guidelines Role and Responsibilities Partnering and collaborating with key stakeholders R&D teams to ensure that appropriate Quality support is provided to Summit Clinical and pre clinical programs Ensuring end to end quality management through proactive compliance based on Clinical Development Plan CDP Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions Supporting CRO relevant meetings when necessary to provide quality overview training to relevant stakeholders Providing support during the development and execution of Corrective and Preventive Actions CAPAs Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined implemented and closed Support formal investigations of issues as they arise ensuring timely escalation to line management if critical incidents are not resolved in due course Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary QA support in interactions with internal and external contacts and Health Authorities HA as appropriate In collaboration with the Global QA team ensure inspection management by assisting in preparing program teams for FDA EU and key HA pre approval and sponsor monitor inspections; provide inspection management support and follow up post inspections Support in providing interpretation of regulations and company process standards guidelines policies and procedures to personnel for assigned programs or for continuous improvement projects Supporting or leading development and driving the implementation of studyprogram specific quality plans to ensure proactive management of quality Supporting rectifying any necessary vendor relevant issues identified for the assigned program Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders Perform internal audits as applicable All other duties as assigned Experience Education and Specialized Knowledge and Skills Bachelors Degree in Life Sciences Pharmacy or Nursing required Masters Degree or other advanced degree preferred Minimum of 5 or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred Thorough understanding of international GCPGLP regulations including FDAEU GCP ICH pharmacovigilance new drug regulations other key HA guidances and current industry practice preferred Ability to travel up to 20Proficient user of standard MS Office suite eg Word Excel experience using electronic document management systems and document review tools desirable Strong computer and database skills Attention to detail accuracy and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking problem solving ability to work independently Must be able to effectively multi task and manage time sensitive and highly confidential documents Communicate effectively and articulate complex ideas in an easily understandable way Prioritize conflicting demands Work in a fast paced demanding and collaborative environment The pay range for this role is 139000 163000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team at recruitingsmmttxcom to obtain prior written authorization before referring any candidates to Summit

Our Company has constructed a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company's longstanding dedication to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product. The focus for the position includes all aspects of Shop Floor QA oversight supporting Third Shift/Night Shift (Sunday - Thursday 10:00 PM to 6:30 AM Shift. Require flexibility for Holidays and weekends.) Responsibilities Reporting to the Quality Assurance Organization, will independently manage Shop Floor Quality Assurance team on second shift. Lead a Shop Floor QA team to provide end-to-end QA support for Production Support & Media, Drug Substance and Drug Product throughout the project lifecycle. Ensure all aspects of the Shop Floor QA proceed in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical alarm management, environmental monitoring incursion/excursion response. Will support and prepare Set-up Activities for SFQA First Shift (Days). Support Operations and the Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (e.g., CLUE and SAP). Support and maintain a "Safety First", " Quality Always" environment with participation in Site GEMBAs for Safety and Quality Compliance. Escalate and collaborate quality and compliance issues as needed through established site Tiers. Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the SFQA Area. Makes decisions guided by policies and procedures that impact the team's ability to meet performance objectives and metrics. Consults on an as-needed basis with next level manager on more complex decisions. Actively sponsor and develop a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members. Support compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR). Consults on an as-needed basis with next level manager on more complex decisions. Minimum Required Education and Experience: Bachelor's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with five (5) years in the pharmaceutical industry or highly regulated industry. OR Master's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with three (3) years in the pharmaceutical industry or highly regulated industry Required Experience and Skills: Minimum two years in aseptic manufacturing or other clean room environment Minimum one year in people management or equivalent direct leadership experience. Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends. Effective decision making, problem solving and communication. Ability to manage multiple priorities. Demonstrated ability to work in fast-paced, complex environments and escalate appropriately. Schedule: Initial training will begin on Day Shift before transitioning to Third (3rd) Shift Preferred Experience and Skills: GMP quality experience with media, biological drug substance and drug product. Strong Background in cGMP document review and approval. Strong background in cGMP compliance standards (QMS, EHS, and Site SOPs) Independent, self-directed strong skill sets in planning / scheduling, and time management. Experience with Quality Risk Management. Experience with Deviation Management. Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. RCA (Root Cause Analysis) with problem-solving experience utilizing MPS / LSS tools, including demonstrated proficiency in MPS 8-Step Problem Solving. Software Proficiency: Microsoft Excel, Work, PowerPoint, Teams. Required Skills: Analytical Problem Solving, Analytical Problem Solving, Analytical Thinking, Biochemistry, Biological Engineering, cGMP Compliance, Chemical Engineering, Decision Making, Detail-Oriented, Driving Continuous Improvement, Good Manufacturing Practices (GMP), Inspection Readiness, Key Performance Indicators (KPI), Management Process, People Leadership, People Management, Policy Procedures, Production Support, Quality Assurance (QA), Quality Auditing, Quality Control Systems, Quality Documentation, Quality Management, Quality Management Standards, Quality Management Systems (QMS) {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $94,300.00 - $148,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 2nd - Evening, 3rd - Night Valid Driving License: No Hazardous Material(s): Cleaning Supplies Job Posting End Date: 12/21/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lonza Pharma & Biotech is looking for a Manager, QA Compliance & Validation to join our Quality Assurance team in Bend, OR. This is an exciting opportunity to lead a high-performing QA team and ensure compliance across pharmaceutical development and manufacturing. Your work will help shape processes that improve lives worldwide. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Competitive compensation programs that recognize high performance. Medical, dental, and vision insurance. Access to global benefits: *************************************** Key Responsibilities: Support internal and external audits and regulatory inspections as a QA expert. Train staff on cGMP and regulatory standards. Oversee compliance evaluations for development and manufacturing activities. Identify and validate corrective and preventive actions (CAPA). Develop workflows and compliance metrics to improve efficiency. Supervise QA staff and manage quality systems documentation. Review and approve regulatory documents. Key Requirements: Bachelor's degree or equivalent experience. Significant experience in the pharmaceutical or biotech industry. Strong compliance and regulatory knowledge. Prior management experience with leadership skills. Familiarity with GMP (Good Manufacturing Practices) preferred. Excellent communication and collaboration skills. Ability to work independently and as part of a team. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

SummaryThe Quality Assurance Manager is responsible for strategic oversight and leadership direction within the Production QA function to include In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Supplier Quality while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures. Associate provides business, technical, and production support, as required; provides technical guidance to employees, as required; develops processes and procedures; has in-depth Quality Assurance expertise.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities: Effective implementation of the site QMS Responsible for strategic oversight and leadership direction of In-Coming Inspection, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation and Supplier Quality. Knowledge of FDA regulatory requirements (QSRs - 21 CFR Part 820) Knowledge of International regulatory requirements (ISO 13845, MHRA GMPs, etc.) Responsible for Production and Process Controls from a Quality perspective Serves as a technical resource for all QA activities Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue Advises others on a variety of topics within own functional area Tracks internal trends and suggests process improvements based on observations Leverages the appropriate resources to provide solutions for internal/external customers Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns Identifies implications/conclusions from the logical analysis of a complex situation or issue Serves as the QA subject matter expert (SME) for internal/external regulatory compliance audits Drives team to achieve established goals in proactive and pragmatic manner; adjusts plan of action accordingly to maneuver obstacles and achieve success Manages budget for own area, allocates resources and delegates accordingly, applying knowledge of profit drivers within own area / department Minimum requirements: Education: Bachelor of Science degree in an engineering or related field. Minimum 7 years' experience in quality, with at least 3-5 years in the medical device industry or pharmaceutical industry. Minimum 2-3 year's management experience Experience in interface with Domestic and Foreign government agencies. (managing audits, Front room experience) CAPAs and validation. Preferred requirements: Experience with SAP preferred Experience in Lean/Six Sigma preferred Computer proficiency in Microsoft Office (Word, Excel, Power Point, Project, and Outlook) Physical Demands: Must be able to lift, push/pull, and carry up to 25 pounds Must be able to wear appropriate personal protective equipment as required Position requires sitting or standing for long hours Use of hands and fingers to manipulate office and calibration equipment is required At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA TX - El Paso - Northwestern Dr.Additional LocationsWork Shift

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description The Quality Assurance Manager oversees assigned laboratories to ensure compliance with company policies and procedures, implementation of a robust and effective Quality System, and employment of continuous improvement activities. This includes identifying or developing quality management tools, assessing risks and leading root cause investigations, evaluating company-wide trends for weaknesses and opportunities to advance the company's leadership position in the environmental industry, and training quality staff in the implementation of Quality Systems, techniques, and tools. Quality Assurance Manager responsibilities include, but are not limited to, the following: * Ensure adherence to highest quality and efficiency standards in laboratory operations * Lead team, schedule, and train employees; ensure coverage and performance; foster morale and teamwork * Lead interventions in laboratories with inadequate Quality Systems or management * Review assigned laboratories' monthly reports to stay current with laboratory issues and achievements * Review audit responses for assigned laboratories as needed * Compile Quality System metrics to monitor the status and performance of assigned laboratories * Monitor laboratory certification activities to ensure no major losses of certifications * Investigate issues raised by clients, QA, sales, and other departments to find root cause, implement corrective action, and document proper response * Perform internal investigations of suspected data integrity related and/or ethics violation issues * Provide review and comments on state, client, TNI, and federal agency programs and requirements * Monitor regulatory and accreditation activities for business opportunities and threats * Research Quality Systems information and stay abreast of new practices to maintain knowledge and provide guidance * Participate in environmental industry committees or organizations to contribute to industry-wide initiatives that can impact the company * Identify and/or develop model Quality System tools, policies, and procedures, and make these available for adoption within the laboratories * Develop and participate in the Quality Management Training for new and prospective quality management staff * Coordinate quality assurance and technical training courses, as applicable * Assist Laboratory Directors/BUMAs in QA personnel decisions including: staffing, hiring, evaluations, and disciplinary actions as requested * Attend meetings to stay current with industry trends and QA programs * Participate in the Laboratory Information Management System (LIMS) oversight and standardization * Assist with internal Quality Systems Audits as needed Qualifications The ideal candidate would possess the following skills and knowledge: * Strong leadership, initiative, and teambuilding skills * Knowledge of environmental laboratory accreditation requirements * Quality Assurance and Quality Control principles * Statistics and the fundamental application in an environmental laboratory * Root cause analysis and corrective action principles * Change management techniques and group dynamics * Knowledge of environmental chemistry, regulatory methods and accreditation requirements, and instrumental techniques * Experience with laboratory operations * Strong analytical, logical, and negotiating skills * Strong interpersonal skills and leadership abilities * Ability to handle multiple priorities * Strong computer, scientific, and organizational skills * Excellent communication (oral and written) skills and attention to detail * Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude * Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Basic Minimum Qualifications: * BS degree in a science, combination of QA experience and knowledge of the environmental testing industry may substitute for a degree. * Minimum 5-10 years of environmental laboratory experience and 5 years QA experience. Advanced degree may substitute for experience. * Authorization to work in the United States indefinitely without restriction or sponsorship * Professional working proficiency in English is required, including the ability to read, write, and speak in English. Additional Information Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with additional time as needed. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Quality Assurance Manager-Parenteral (Full Time) At Nivagen as Quality Assurance manager you will be responsible for overseeing and managing all QA activities related to the manufacturing of sterile injectable (parenteral) products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (e.g., FDA, EMA, MHRA). The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement. Responsibilities: Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness. Provide triage support across departments to address moderate quality issues, ensuring timely escalation to management when necessary. Review and approve deviations, including the associated investigation reports, and corrective/preventative actions. Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations. Review and approve sampling protocols, risk assessments, and master batch records. Author, review and approve SOPs as appropriate for both Operations and Quality. Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities. Participate in internal audits, support regulatory inspections or customer audit activities, as needed. Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance. Assist in the development or assignment of training to key stakeholders related to QMS. Contribute to the preparation of Periodic Quality Reviews. Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Quality standards. Support the implementation of a quality culture and best practices within the affiliate organization Qualifications: Education/Experience: Candidates with a Bachelor's degree must have at least 10 years of relevant experience; those with a Master's degree require 5+ years of experience. Strong background in manufacturing and quality assurance within the pharmaceutical or biotechnology industry is essential. Knowledge, Skills, and Abilities: Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards. Proactive approach and strong critical thinking skills. Must be able to work in a team environment within own team and interdepartmental teams. Excellent communication and interpersonal skills. Experience in quality administered systems. Strong organizational skills and attention to detail. Experience with regulatory compliance and documentation. Ability to mentor and review the work of other colleagues. Knowledge of electronic systems such as Compliance wire., Veeva, Track wise, SAP, LIMS, Maximo, Microsoft Office etc. Job Requirements: This role is primarily day shift, Monday - Friday, with 24/7 support of manufacturing as quality issues arise. Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements. Collaboration skills and the ability to independently engage with a wide range of colleagues, and management to gather the input and background knowledge needed to complete assignments. Must be able to gown for entering controlled areas. Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.). Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs. Overtime and weekend work may be required. Individuals must be available via cell phone (on-call). Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: Pay range $85,000-$95,000 per Year / $40/hr. (for hourly basis) Relocation assistance available Annual bonus Eligibility (Based on yearly company and personal performance) Medical, dental and vision coverage Paid time off plan 401k savings plan with No matching Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow. Benefits Include: 4 weeks accrued paid vacation and 13 paid holidays. 401(k) match with company profit sharing. Tuition reimbursement and Student Loan repayment program. Great Health, personal, and family benefits starting day 1. Position Summary The Materials Release QA Manager is responsible for QA oversight of incoming inspection, warehousing and shipping, sampling and release of raw materials, packaging and labeling components, and contracted intermediates/finished goods. This position is responsible for the direct supervision of the teams performing these functions. As needed, the Materials Release QA Manager will interface directly with customer and internal auditors, regulatory inspectors and provide guidance and support in the interpretation and enforcement of regulatory guidelines. Hours: 1st shift. Position Responsibilities Oversee and manage the incoming inspection and raw material release teams. Ensure the accurate and efficient preparation of all release documents (raw material, certificates/declarations, etc.). Ensure all materials are compliant with the registered specifications and that releases occur in timely manner. Support the quality of materials and products in a GMP environment. Create and revise material specifications. Ensure the appropriate specifications are in-place. Monitor and identify regulatory/compendial changes affecting raw material requirements. Support Periodic Product Reviews (PPRs) for Raw Materials and Packaging Components Identify and communicate metrics (e.g., release timelines); track RFT on incoming shipments. Identify and escalate areas of risk, particularly those with vendors and materials. Identify and drive to resolution areas of risk associated with vendors and materials. Support the qualification of new vendors/materials. QA oversight of the in-coming materials and outgoing finished goods warehouses. Support site project initiatives. Lead/participate in investigations and change management activities. Support regulatory agency, customer, and internal audits. Support market action activities. Maintain the department Standard Operating Procedures and compliance with the Zoetis Quality standards. Other responsibilities, as assigned. Education and Experience B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience. Technical Skills and Competencies Required Experience with label printing and/or plastic molding (preferred). Leadership and/or supervisory (preferred) experience. Knowledge of USDA, FDA, and EU regulations, with an emphasis on FDA regulations and requirements. Experience in change management processes, regulatory compliance, quality operations, manufacturing for vaccines and/or bio/pharmaceutical manufacturing operations. Demonstrated investigation, problem solving and risk assessment/management skills. Organizational skills, attention to detail. Excellent verbal and written communication skills . Works effectively in a team-based environment. Demonstrated ability to work with internal and external colleagues. Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Veeva Vault, ERP (SAP) and Laboratory Information Management (LIMS) systems. Physical Position Requirements Ability to sit, stand and walk. Some travel may be required. Occasional overtime/weekend work Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. * Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. * Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. * Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. * Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. * Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. * Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. * Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. * Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. * Ensures Quality Assurance goals and objectives are identified and met * Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director * Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelors' degree in Life Science or equivalent course of study is required. * 10 years progressive experience in QA Pharmaceutical environment required. * 5-10 years management experience required. * Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. * Excellent oral and written communication skills including strong technical writing skills. * Strong organizational skills, planning skills and team-building. * Ability to work independently and deliver timely results. * Ability to lead cross functional teams, resolve conflicts and disagreements. * Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. Ensures Quality Assurance goals and objectives are identified and met Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors' degree in Life Science or equivalent course of study is required. 10 years progressive experience in QA Pharmaceutical environment required. 5-10 years management experience required. Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. Excellent oral and written communication skills including strong technical writing skills. Strong organizational skills, planning skills and team-building. Ability to work independently and deliver timely results. Ability to lead cross functional teams, resolve conflicts and disagreements. Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Job DescriptionDescription: At Cosmos Corporation, we make health and wellness products that help people and pets live better lives. From our O'Fallon, Missouri headquarters, we manufacture high-quality, natural liquid products with ingredients people trust. We are looking for a new ideal team player as a Quality Assurance Manager in our Quality department! The Quality Assurance Manager is responsible for maintaining Cosmos's Quality Management System and maintaining customer expectations across internal teams and external stakeholders. You will be leading and coaching a small department while managing the document control system, supporting the implementation of new products, renewing certifications, issue resolution, improving quality standards, communicating with suppliers, and other responsibilities. Develop and maintain programs related to providing safe, high-quality products. Develop and facilitate Good Manufacturing Practices (cGMP) training for managers and employees. Maintain and manage current ISO 9001:2015 standards. Familiarity with FDA Regulations, including 21 CFR 211. Maintain and continuously improve the Quality Management System. Address and resolve nonconformities and complaints, identify trends, and compliance information to managers and supervisors. Continuous review, update, and train on standard operation procedures (SOPs) and work instructions (WIs). Ownership and maintenance of Cosmos's Hazard Analysis and Critical Control Point (HACCP) Plan. Lead and perform internal and external audits and report findings to internal stakeholders at a regular cadence and provide recommendations for adjustments based on findings. Responsible for upholding customer, consumer, regulatory agency, and certification body expectations related to Cosmos' business processes and products. Provide timely insight and input through involvement with the new product development and product line extensions. Maintains the Document Control Program, including files and tracking databases. Ownership and management of Cosmos's Supplier Quality Program by tracking supplier data, performing supplier audits, collaborating with the Supply Chain Team, and participating in Vendor Reviews. Provide leadership, coaching, and support for direct reports. Lead, support, and respond to customer, regulatory, and third-party audits of the Cosmos Manufacturing Facility. Requirements: You will hold a Bachelor's Degree in food science or a related field. Preventive Controls Qualified Individual (PCQI) Certification is preferred. Five plus years of experience in the field of quality assurance, quality regulations, and implementation and experience in leading a team. Competencies Technical Capacity. Organizational Skills. Teamwork Orientation. Communication Proficiency. A Week In The Life Your work schedule will be Monday through Friday starting at 8:00 a.m. to 5:00 p.m. Weekly tasks for your role will be group huddles, leading and participating in project team meetings, oversight of document control, non-conformance processes, cross-department collaboration through several touchpoints, planning and execution of new products on the manufacturing floor, and participating in issue resolution. On Wednesdays, you will head to the lunch room at 11:40 a.m. for the Cosmos Minute, where the entire company meets at 11:45 a.m. to learn about other team members and special company announcements at Cosmos. What's In It for You Comprehensive medical, dental, and vision insurance. 401(k) with company contribution. Paid vacation, sick leave, holidays, and 5 Mission Days. Short- & long-term disability, life insurance, and supplemental coverages. Development programs. A positive, purpose-driven culture where people truly care about one another. Cosmos is a company that supports and invests in its employees. We have a healthy workplace culture guided by a clear vision, mission, promise, and values! Our culture is intentionally fostered daily by how employees live out our values. The result is a place where employees genuinely enjoy coming to work every day! Equal Opportunity Employer Cosmos Corporation is an equal-opportunity employer. We prohibit discrimination and harassment of any kind as outlined by federal, state, or local laws. Cosmos Corporation makes hiring decisions based solely on qualifications, merit, and business needs at the time.

The Quality Assurance Manager, Contract Manufacturers (CMOs) oversees all quality-related activities for external manufacturing partners producing OTC semisolid drug products. This includes compliance with FDA 21 CFR Part 210/211, CHPA guidelines, ICH Q7/Q9/Q10, supplier quality expectations, and internal QMS requirements. Reporting to: Director, Quality Services Location: Johnson City, TN - onsite Responsibilities/Essential Duties: Provide quality oversight of CMOs producing OTC semisolid products. Develop and maintain Quality Agreements. Plan and execute GMP audits; support regulatory inspections. Review batch documentation, deviations, and OOS/OOT investigations. Provide technical QA oversight for semisolid manufacturing processes. Oversee complaint investigations, CAPA management, and effectiveness checks. Evaluate and approve change controls from CMOs. Oversee stability program execution and data review. Manage supplier and material quality, including qualification, requalification, and specification control. Ensure supplier notifications, investigations, and raw material issues are managed per GMP. Support continuous improvement and QMS enhancements. Office-based with travel to CMOs and supplier sites. Ability to wear PPE as required. Basic Qualifications: Bachelor's degree & 5+ years' directly related experience. Preferred Qualifications: Bachelor's degree in scientific or engineering field. 5-10 years' QA experience in pharmaceuticals, OTC, or semisolid manufacturing. Experience managing CMOs and suppliers. Knowledge of FDA 21 CFR 210/211 and ICH Q guidelines. Technical expertise in semisolid manufacturing quality standards. Strong auditing and communication skills. Proficiency with electronic QMS platforms. Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus. Flexible PTO, holidays, and parental leave. Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Requirements You will hold a Bachelor's Degree in food science or a related field. Preventive Controls Qualified Individual (PCQI) Certification is preferred. Five plus years of experience in the field of quality assurance, quality regulations, and implementation and experience in leading a team. Competencies Technical Capacity. Organizational Skills. Teamwork Orientation. Communication Proficiency. A Week In The Life Your work schedule will be Monday through Friday starting at 8:00 a.m. to 5:00 p.m. Weekly tasks for your role will be group huddles, leading and participating in project team meetings, oversight of document control, non-conformance processes, cross-department collaboration through several touchpoints, planning and execution of new products on the manufacturing floor, and participating in issue resolution. On Wednesdays, you will head to the lunch room at 11:40 a.m. for the Cosmos Minute, where the entire company meets at 11:45 a.m. to learn about other team members and special company announcements at Cosmos. What's In It for You Comprehensive medical, dental, and vision insurance. 401(k) with company contribution. Paid vacation, sick leave, holidays, and 5 Mission Days. Short- & long-term disability, life insurance, and supplemental coverages. Development programs. A positive, purpose-driven culture where people truly care about one another. Cosmos is a company that supports and invests in its employees. We have a healthy workplace culture guided by a clear vision, mission, promise, and values! Our culture is intentionally fostered daily by how employees live out our values. The result is a place where employees genuinely enjoy coming to work every day! Equal Opportunity Employer Cosmos Corporation is an equal-opportunity employer. We prohibit discrimination and harassment of any kind as outlined by federal, state, or local laws. Cosmos Corporation makes hiring decisions based solely on qualifications, merit, and business needs at the time. Salary Description $75,000-$90,000/year

7,000 Diseases - 500 Treatments - 1 Rare Pharmacy PANTHERx is the nation's largest rare disease pharmacy, and we put the patient experience at the top of everything that we do. If you are looking for a career in the healthcare field that embraces authentic dedication to patient care, you don't need to look beyond PANTHERx. In every line of service, in every position and area of expertise, PANTHERx associates are driven to provide the highest quality outcomes for our patients. We are seeking team members who: Are inspired and compassionate problem solvers; Produce high quality work; Thrive in the excitement of the ever-challenging environment of modern medicine; and Are committed to achieving superior health outcomes for people living with rare and devastating diseases. At PANTHERx, we know our employees are the driving force in what we do. We cultivate talent and encourage growth within PANTHERx so that our associates can continue to explore their interests and expand their careers. Guided by our mission to provide uncompromising quality every day, we continue our strategic growth to further reach those affected by rare diseases. Join the PANTHERx team, and define your own RxARE future in healthcare! Location: Pittsburgh, PA (Hybrid) Classification: Exempt Status: Full-Time Reports To: Director, Quality Purpose The Quality Manager, New Programs, is a key member of the Quality team supporting the design, implementation, and oversight of new drug programs in concert with the Implementation, Operations, IT, and Clinical teams. This role ensures that all service agreements, business rules, and accreditation requirements (URAC, ACHC, and NABP) are accurately incorporated into workflows and procedures, while ensuring patient safety and quality of care. The Quality Manager, New Programs, will validate patient information system workflows, identify process gaps, support program launch activities, and conduct post-launch audits to ensure compliance and continuous improvement. Responsibilities Promotes a culture of safety, transparency, and continuous learning in alignment with Just Culture and continuous quality improvement principles. Leverages pharmacy background and working knowledge of accreditation standards to support new programs during the implementation process. Reviews and interprets manufacturer service agreements and business rules to identify quality impacts for the program and ensure alignment with pharmacy operations and accreditation requirements. Collaborates with cross-functional teams (implementation, operations, clinical, IT, and training) to validate workflows in the patient information system and to ensure seamless integration of quality practices. Tests patient system workflows for new drug program launches, ensuring accuracy, efficiency, and compliance. Identifies and escalates process gaps or risks that may negatively impact patient care, program performance, or accreditation compliance. Conducts quality audits following program launches to ensure a consistent, high-quality patient experience and compliance with service agreements, operational standards, and internal SOPs. Leads and supervises one or more Quality Specialists in auditing programs after launch. Documents findings, trends, and corrective actions, and provides recommendations for process improvement. Attends external implementation meetings to understand patient journey developments and manufacturer expectations Shares findings from internal and external audits, assesses impact, and provides recommendations for changes. Collaborates with leadership to align quality initiatives with business objectives and patient safety priorities. Serves as the subject matter expert for URAC, ACHC, and NABP accreditation standards. Supports internal audits and on-site or virtual accreditation surveys. Other duties as assigned. Required Qualifications: Bachelor's degree in pharmacy, nursing, or a related field; or equivalent experience. Minimum of three (3) years of experience in specialty pharmacy, quality, accreditation, or program implementation. Strong analytical and problem-solving skills with attention to detail. Ability to interpret service agreements, contracts, and accreditation requirements. Proficiency in patient information systems, workflow validation, and process auditing. Excellent written and verbal communication skills. Ability to work collaboratively across departments and with external stakeholders. High degree of self-direction and ability to work independently with little or no supervision. Working knowledge of quality improvement and performance management concepts. Demonstrated ability to lead projects of at least moderate complexity. Ability to manage multiple projects simultaneously, adjusting priorities as needed to meet project deadlines. Preferred Qualifications: Previous experience in a quality role. Experience with process design. Experience with program launches in specialty pharmacy or pharmaceutical manufacturer partnerships. Prior experience supporting accreditation surveys and audits. CPHQ (Certified Professional in Healthcare Quality). Work Environment: This job works in a professional office and home office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and fax machines. Physical Demands: While performing the duties of this job, the employee is regularly required to sit, talk or hear. The employee frequently is required to stand; walk; use hands and fingers to handle or feel; and reach with hands and arms. Visual acuity is necessary for tasks such as reading or working with various forms of data. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential function of the job.