Senior Specialist Quality Assurance jobs at Merck - 694 jobs

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and/or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development.**ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:**These may include but are not limited to:General* Provide GCP quality assurance strategy and oversight of QA GCP operations* Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies* Develop and implement risk management strategies to identify, assess, and mitigate risks* Drive effective initiatives that foster a culture of quality and continuous improvement* Successfully collaborate on multiple projects with cross-functional stakeholders* Lead investigations of significant complexity* Prepare and present to executive management* Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects Audit Management* Develop a plan with CROs for clinical sites' audit execution* Manage clinical site, TMF, and GCP and GLP vendor audit activities* Generate and/or review and approve overall GCP QA audit plans and schedules* Generate and/or review and approve audit trend reports* Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends Study Team Support & Issue Escalation Management* Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback* Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required* Manage quality events, CAPAs, and deviations* Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs.* Provide guidance and support to Trial Master File activities Quality Systems / Inspections / Infrastructure* Ensure adequate systems and controls are in place for GCP compliance* Identify and address quality systems gaps, including internal processes and personnel GCP training* Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs* Author, review, or revise SOPs related to clinical and non-clinical studies* Develop and provide GCP training* Support regulatory inspection activities* and GCP inspection readiness activities* Prepare internal team, clinical sites, and vendors for inspection readiness* Thoroughly review clinical study documents* Perform breach assessments* Oversee quality vendor management and governance for GCP and GLP vendors* Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor* Contribute and present GCP quality events and metrics at the Quality Management Review meeting* Support other Quality Assurance and Quality Systems activities* Other duties as assigned.**Education and Experience**Required:* Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)* Minimum of 8 years of working in a GCP QA function* Previous experience leading inspection readiness and audits* Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines* Hands-on experience in developing and implementing GCP procedures* Strong working knowledge of GCP and GLP regulations* Proven ability to cultivate and develop relationships with cross functional teams and vendors* Demonstrated leadership ability to identify, manage and develop QA teams* Must be able to make critical and strategic decisions based on risk-assessments* Capable of managing multiple projects simultaneously* Excellent communication and listening skills Preferred:* Auditing certification is a plus**Physical Demands and Work Environment:**Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.**Travel:**You may be required to travel for up to 10% of your time.**The Anticipated Base Salary Range: $1****76,000 - $220,000***In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.**Equal Opportunity Employer:**Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.**Vaccination requirement:**Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone #J-18808-Ljbffr

A leading pharmaceutical company in San Diego seeks a Director, Quality Assurance (GCP) to oversee GCP QA systems, ensuring compliance with regulatory requirements. The role demands extensive experience in GCP as well as a strong leadership and auditing background. The ideal candidate will have a track record of developing quality strategies and collaborating across multiple teams. Competitive compensation includes a salary range of $176,000 - $220,000, alongside comprehensive health benefits and additional perks. #J-18808-Ljbffr

The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. Responsibilities Develop standardized production, quality, and customer-service standards Identify potential risks before they become a problem, focusing on root cause analysis and preventive action Perform internal and external quality audits and compile detailed reports of findings Build a strong team through coaching, mentoring, specific training and performance evaluations Qualifications Bachelor's degree or equivalent experience in Engineering 5+ years' relevant work experience Highly organized with excellent attention to detail

Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Senior Editorial and Quality Lead (Healthcare Agency)| Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data seeks a meticulous Senior Editorial and Quality Lead to serve as the central hub for editorial excellence across pharmaceutical and healthcare deliverables. This hands-on role owns quality control from post-writing drafts through design, reviews, and client approvals-focusing on grammar, style mastery, layout accuracy, and workflow efficiency. Ideal for an experienced editor passionate about the craft of editing. About the Role The Senior Editorial and Quality Lead will own editorial quality control as the central hub across all deliverables-from post-medical writing drafts through design layouts, internal strategy reviews, and client approvals. This hands-on role encompasses proofreading, light editing, layout verification, and workflow coordination for slides, print materials, digital assets, training modules, and long-form content, serving pharmaceutical and healthcare clients. Work closely with medical writers, designers, strategists, and account teams to ensure grammar, style, accuracy, and layout integrity meet the highest agency and client standards. Key Responsibilities Editorial Quality Control Proofread and edit copy developed by medical writers for grammar, clarity, consistency, spelling, accuracy, AMA Manual of Style, and client-specific guidelines. Verify references, superscripts, citations, medical terminology, numeric values, units, symbols, and data formatting. Perform light editing or rewrites to address minor issues and maintain project efficiency. Brand & Compliance Consistency Ensure content aligns with each client's editorial style, tone, branding expectations, and regulatory requirements (including PI/ISI placement when applicable). Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review designed documents and slides (PowerPoint, InDesign, PDFs) to confirm clean, consistent formatting and layout. Verify alignment between copy and design elements (tables, charts, visuals, callouts); identify inconsistencies in spacing, bullets, alignment, superscripts, or content order that could alter meaning. Process & Workflow Execution Manage editorial checkpoints and coordinate handoffs across medical writers, designers, internal strategy reviewers, and clients on multiple concurrent projects. Implement QC edits directly; track and ensure all internal, client, and MLR feedback is accurately incorporated with proper version control and file naming. Serve as the final quality assurance step before client delivery. Requirements Minimum 4-5 years of editorial or proofreading experience in a healthcare, pharmaceutical, or medical communications agency setting. Strong knowledge of the AMA Manual of Style and the ability to apply client-specific style guides and branding requirements. Experience reviewing healthcare or scientific content with a high level of accuracy for terminology, data, units, and references. Demonstrated ability to manage multiple projects and deadlines in a fast-paced, detail-oriented environment. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (eg, SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision and quality control. Strong communication and collaboration skills for working with medical writers, designers, strategists, and account teams. Education Bachelor's degree in English, Communications, Journalism, or a related field; a life sciences background is a plus but not required for this role. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process To apply, please submit your resume (and, if available, editing samples) directly through this LinkedIn job posting. Candidates selected for the next steps will be asked to complete a brief editing exercise.

A leading biotechnology company is seeking a Senior Medical Science Liaison focused on Nephrology programs. This role entails establishing relationships with healthcare professionals, executing the medical affairs strategy, and delivering scientific information. Candidates should have a minimum of 3-4 years in a similar position, an advanced life sciences degree, and strong communication skills. The position offers a competitive salary and robust benefits, reflecting the company's commitment to employee growth and well-being. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking a Senior Director of Quality Policy and Advocacy to lead global policy initiatives. This role requires extensive experience in Quality strategies, particularly within North American regulatory landscapes. You will be responsible for advocating Gilead's portfolio interests and engaging with stakeholders to resolve complex Quality issues. The ideal candidate will have a strong background in regulatory affairs, leadership skills, and the ability to communicate effectively with diverse audiences. This role offers a competitive salary and benefits. #J-18808-Ljbffr

Core Hours: Monday - Friday, 8:00 am - 5:00 pm Purpose and Scope Provide direct supervision of a team of analysts responsible for the testing and release of Tolmar products in support of manufacturing timelines. Essential Duties & Responsibilities Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items. Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes. Escalate and communicate items which arise per the timelines specified in the department escalation strategy. Execute all business and department goals and initiatives on time. Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments. Issue all Certificates of Analysis within 2 business days of last test completion. Generate, monitor and report weekly team and analyst KPIs. Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples. Strive to balance workload across all sites and teams to ensure adequate resource allocation. Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time. Provide assistance, training and leadership for direct reports through utilization of the OTD resources. Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix. Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals. Create and revise developmental plans to help employees grow their skills and advance their careers. Monitor and discuss progress of employee's performance, growth and development in one on ones utilizing the career ladder and KPIs. Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates. Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days). Support and execute all potential 3-day field alert investigations and actions expeditiously. Submit document change requests for all document updates and minimize document revisions for routine updates where possible. Ensure all samples logged into the LIMS system are submitted correctly. Identify, and complete cost savings initiatives and facilitate continuous improvement. Participate in leadership development activities and take an active role during department and company activities. Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained. Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues. Conduct and coordinate laboratory investigations, and all associated actions. Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports. Participate in project teams, company and department meetings, third party audits, and regulatory audits. Monitor departmental spending to stay within the established budget. Demonstrate leadership aptitude in technical functions and people management. Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions. Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Accountable for meeting departmental and compliance timelines. Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures. Participate in the interview and selection process for candidates, as required. Perform other duties as required by business demands. Knowledge, Skills & Abilities Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality. Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology. Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions. Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage. Knowledge in analytical method validation and instrument qualification. Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work. Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors. Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department. Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices. Knowledge of analytical troubleshooting and product investigation. Effective oral and written communication. Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,. Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use. Ability to coordinate activities to assure customers' needs are met in terms of sample analysis cycle time. Core Values The Quality Control Supervisor is expected to operate within the framework of Tolmar's Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Education & Experience Bachelor's degree in science, preferably in Chemistry or Biochemistry, or Microbiology. Six or more years' experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting. Supervisory or team lead experience is preferred. Working Conditions Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals. Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality to meet important timelines in a high throughput lab. Business demands present a need to work extended hours. On call weekend support will be required with a minimum of 8 on call weekends each year. Compensation and Benefits Annual pay range $100,000 - $105,000 depending on experience Bonus Eligible Benefits information: careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. Position Summary: The Clinical Quality team strives to ensure that the clinical quality management system (QMS) is optimized to foster a culture where quality innovation matches the company's goals. The Senior Manager, Clinical QA is responsible for providing strategic input to GCP-related compliance activities, managing audits of service providers and providing QA oversight of Ocular Therapeutix sponsored trials. This position will implement and optimize the risk-based quality strategy in coordination with the functional areas and Quality team employing a solution-oriented approach to quality management, quality partnership, quality improvement, and quality excellence. Principal Duties and Responsibilities include the following: • Plan and conduct audits of suppliers, investigator sites, and internal processes to assess compliance with the applicable regulatory requirements, guidelines, standards, agreements and / or Standard Operating Procedures. • Write and distribute audit reports • Collaborate with cross-functional teams to ensure timely resolution of audit findings and follow up on corrective and preventive actions (CAPAs). • Manage audit scheduling, reporting, and tracking of audit activities, including audits outsourced to third parties • Evaluate the design, feasibility, and operational integrity of clinical trial protocols • Identify gaps or weaknesses in protocol implementation that could impact trial participant safety, data reliability, or regulatory compliance. • Ensure consistent implementation, use and review of SOPs. • Escalate issues to management in a timely manner implementing appropriate solutions, including preventive actions. • Collaborate with internal cross-functional teams to improve quality and increase efficiencies. • Support Ocular Therapeutix Quality Management System (QMS) by assisting with the development and updating of standard operating procedures and other controlled documents. • Lead functional process improvement initiatives to drive efficiencies and effectiveness of Clinical Quality Assurance processes. • Provide guidance and training on GXP regulations, corporate standards, and quality policies • Provide support for inspection readiness and inspections • All other duties as needed or assigned. Qualification Requirements: • A minimum of a bachelor's degree in Life Sciences or equivalent • Experience may be substituted for education. • 8+ years of experience in the pharmaceutical / biopharmaceutical / CRO industry (experience in GXP roles). • Strong GCP auditing experience • Strong understanding of ICH-GCP, FDA regulations and guidance, as well as international requirements and standards • Excellent analytical, communication and problem-solving skills • Ability to manage multiple simultaneous projects • Well-organized, meticulous and thorough • Commitment to diversity, equity, and inclusion Working Conditions • Remote based • Willingness to travel up to 40% (including international travel) Salary Range$170,000-$185,000 USD Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at ************************************** For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond. You can view our latest corporate deck and other presentations here. As the Sr. Manager GCP Clinical Quality reporting to the Senior Director GCP Quality, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross-functional study teams ensuring GCP/GVP compliance, assisting in identifying and communicating clinical trial-related risks and opportunities for process improvement as well as reviewing / approving study-related documents and plans and supporting audits. This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and will require up to 20% travel. Your work will primarily encompass: Assist in preparation for, and support of health authority inspections Supporting the training of cross-functional teams on inspection expectations and processes Verifying the completeness, accuracy, and availability of inspection-ready documentation Contributing to the development of inspection storyboards and key messaging Facilitating and participating in mock inspection activities Serving in front-room and back-room roles as required during inspections Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP Oversee clinical compliance and quality within the context of cross-functional study teams Continue to improve/refine Olema's risk based GCP compliance approach globally Support Quality Management System (QMS) including, but not be limited to: QA review/approval of deviations, CAPAs and change controls Draft, review, and approve policies, procedures and work instructions Ideal Candidate Profile >>> Key Requirements A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role. Knowledge Bachelor's degree is required, advanced degree (MS, PharmD, PhD) preferred Strong understanding of clinical trials and pharmacovigilance reporting Strong understanding of FDA, EMA, and ICH Health compliance requirements Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) Experience Minimum 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors Experience preparing for and supporting regulatory agency inspections, primarily FDA; additional experience with other global regulatory agencies is an advantage Experience writing and reviewing SOPs Experience using QMS (Veeva systems preferred) Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience Attributes: Excellent verbal and written communication skills Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects Ability to work hands-on and be a strong individual contributor The base pay range for this position is expected to be $175,000 - $190,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-CK1 Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end *************. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond. You can view our latest corporate deck and other presentations here. As the Sr. Manager GCP Clinical Quality reporting to the Senior Director GCP Quality, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross-functional study teams ensuring GCP/GVP compliance, assisting in identifying and communicating clinical trial-related risks and opportunities for process improvement as well as reviewing / approving study-related documents and plans and supporting audits. This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and will require up to 20% travel. Your work will primarily encompass: Assist in preparation for, and support of health authority inspections Supporting the training of cross-functional teams on inspection expectations and processes Verifying the completeness, accuracy, and availability of inspection-ready documentation Contributing to the development of inspection storyboards and key messaging Facilitating and participating in mock inspection activities Serving in front-room and back-room roles as required during inspections Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP Oversee clinical compliance and quality within the context of cross-functional study teams Continue to improve/refine Olema's risk based GCP compliance approach globally Support Quality Management System (QMS) including, but not be limited to: QA review/approval of deviations, CAPAs and change controls Draft, review, and approve policies, procedures and work instructions Ideal Candidate Profile >>> Key Requirements A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role. Knowledge Bachelor's degree is required, advanced degree (MS, PharmD, PhD) preferred Strong understanding of clinical trials and pharmacovigilance reporting Strong understanding of FDA, EMA, and ICH Health compliance requirements Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) Experience Minimum 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors Experience preparing for and supporting regulatory agency inspections, primarily FDA; additional experience with other global regulatory agencies is an advantage Experience writing and reviewing SOPs Experience using QMS (Veeva systems preferred) Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience Attributes: Excellent verbal and written communication skills Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects Ability to work hands-on and be a strong individual contributor The base pay range for this position is expected to be $175,000 - $190,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-CK1 Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end *************. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.

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 **************************************.

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Manager Validation QA. The QA Validation Manager will lead and oversee the development, execution, and maintenance of validation programs within a biologics drug substance manufacturing environment. This role requires comprehensive experience across multiple validation disciplines, including equipment, process, computer systems, and cleaning validation. The Validation Manager ensures all validation activities comply with cGMP regulations, internal SOPs, and regulatory expectations, providing technical leadership to ensure the consistent production of high-quality biologics products. Responsibilities include: Participate in establishing and maintaining company validation management principles, standards, and operational requirements (SOPs, templates, guidelines, etc.) to ensure alignment with current regulatory expectations. Assist in maintaining and updating the Master Validation Plan (MVP) to ensure comprehensive coverage and appropriate review cycles. Develop, implement, and maintain validation strategies and plans for equipment, processes, cleaning, and computerized systems. Lead and manage cross-functional validation projects, ensuring on-time completion and compliance with regulatory requirements. Review, approve, and maintain validation documentation including protocols, reports, change controls, and deviations. Perform quality assessments of deviations, CAPAs, and change controls identified during validation activities to ensure timely handling in accordance with quality and validation requirements. Collaborate with manufacturing, quality, engineering, and IT teams to ensure validation activities are integrated with operational requirements. Monitor regulatory changes and industry best practices to identify opportunities for improving validation management processes. Support regulatory inspections and audits by providing validation expertise and documentation. Drive continuous improvement initiatives for validation processes and methodologies. Ensure risk-based approaches are applied to validation programs, including qualification and requalification activities. Additional Responsibilities Support technology transfer and scale-up activities for new biologics products. Participate in internal and external audits as validation subject matter expert. Monitor industry trends, guidance documents, and regulatory updates to maintain compliance. Lead root cause investigations and corrective actions related to validation deviations. Manage validation-related budgets and resource allocation. Job Requirements and Qualifications: Education: Required: Bachelor's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields, Preferred: Master's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields Experience: Required: 5+ years, minimum 2 years in Management, Preferred : 10+ years, minimum 2 years in Management WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. 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. * Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. * Ensure deviation timelines are maintained through inter-department communication. * Facilitate and lead assigned investigations involving multiple investigation areas. * Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. * Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). * Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). * Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. * Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. * Under supervision assist with documentation for the closure of complaint investigations. * Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audits and inspections as required. * Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current in ISO train. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * 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. * Bachelor's degree in a science or engineering field. * ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. * Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * Ability to apply critical thinking to scientific problems and demonstrated knowledge. * Ability to apply statistical quality management concepts. * PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. * Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. 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 Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. 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. * Under supervision, assist with documentation for the closure of investigations. * Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. * Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * 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. * High School or GED diploma required. Associate's degree or equivalent years of experience preferred. * Experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * PC Skills Required (MS Word, Excel). * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. 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 The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. 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. Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. Ensure deviation timelines are maintained through inter-department communication. Facilitate and lead assigned investigations involving multiple investigation areas. Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. Under supervision assist with documentation for the closure of complaint investigations. Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audits and inspections as required. Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current in ISO train. Ensure all work is performed and documented in accordance with existing company policies and procedures. 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. Bachelor's degree in a science or engineering field. ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. Ability to apply critical thinking to scientific problems and demonstrated knowledge. Ability to apply statistical quality management concepts. PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. 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 Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. 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. Under supervision, assist with documentation for the closure of investigations. Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current. Ensure all work is performed and documented in accordance with existing company policies and procedures. 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. High School or GED diploma required. Associate's degree or equivalent years of experience preferred. Experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. PC Skills Required (MS Word, Excel). Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. 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 **************************************.

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Operations On-site QA Specialist This position is responsible for Under minimal supervision from senior team members, executes written procedures associated with on-site Quality Assurance responsibilities focusing on on-site inspection of manufacturing and testing operations. 3rd shift, 4pm-4am, (3 nights on/2nights off, 2 nights on/3 nights off) Responsibilities include: The Operations On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP QA setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the Operations On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below. Conducts on the floor reviews of all manufacturing and testing operations. Performs verifications required to support manufacturing and testing documentation (including but not limited to batch records, cleaning records, logbooks, and test methods). Assists all departments in the identification and evaluation of facility events. Performs on the floor reviews of executed batch records. Assists in the organization and/or the establishment/maintenance of relevant procedures/documents. Assists in audits where necessary. Supports the document control team in issuing records as needed. Performs other duties as assigned Job Requirements and Qualifications: Position will be filled up to the Lead level and determined at discretion of the hiring manager. Specialist Education: Required: Bachelor's Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industry Experience: Required: 2+ years, Preferred: 5+ years Senior Education: Required: Bachelor's Degree or above in a Scientific discipline or 5+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 7+ years QA experience in a regulated industry Experience: Required:5+ years, Preferred: 7+ years Lead Education: Required: Bachelor's Degree or above in a Scientific discipline or 7+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 10+ years QA experience in a regulated industry Experience: Required: 7+ years, Preferred: 10+ years WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an On-Site QA Specialist. Under minimal supervision from senior team members, this position is responsible to execute written procedures associated with on-site Quality Assurance responsibilities including but not limited to on-site inspection, batch record review and raw material inspection/release. Responsibilities include: • The On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below. • Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event. • Reviews executed batch records. • Perform inspection and disposition of raw materials on the basis of approved specifications. • Writes deviations, investigations, change controls and/or CAPAs. • Performs shipping release procedures. • Assists in the preparation of Annual Product Review documentation for all SPL Marketed Products. • Administrative support for the on-site QA department such as generation of DCR's, file organization, data compilation, training activities, etc. Job Requirements and Qualifications: Position will be filled up to the mid-level and determined at discretion of the hiring manager. Education: Bachelor's degree or above required; Bachelor's degree or above in Scientific discipline preferred Experience: 2 plus years of experience required; 5 plus years of experience preferred WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.