Senior Specialist Quality Assurance jobs at Mallinckrodt - 407 jobs

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

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The Specialist, QA Shop Floor, Cell Therapy will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shifts Available: 6pm - 6am, rotating scheduling including holidays and weekends, onsite Responsibilities: Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy. Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members. Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures. Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques. Provide quality oversight for pre-planned return to service plans. Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners. Identify and propose improvements to programs, procedures, and practices. Review manufacturing batch records or QC testing records to ensure compliance with approved procedures. Review and provide feedback on documents such as forms, logbooks, and procedures. Maintain compliance with assigned learning plan. Provide integration support of newer team members. Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. Participate in quality and shift meetings. Build and maintain relationships with core partner functions and seek collaborative solutions. Share data/knowledge within team by acting as a champion for quality-culture. Knowledge and Skills: Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking. Ability to understand, follow, and apply internal policies, procedures, and quality principles. Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management. Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions. Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work. Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints. Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills. Active listening skills to understand diverse working perspectives. Contributes to a positive team environment. Able to independently make decisions based on data and facts, and recognizes when to escalate Seeks opportunities for improvement to quality and operational problems. Ability to work within pharmaceutical cleanroom environments. Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Basic Requirements: Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered. 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. * BMSCART #LI-ONSITE GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $83,540 - $101,228 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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 global biotechnology company is looking for a Senior Medical Science Liaison (Sr MSL) specialized in Nephrology to foster relationships with healthcare professionals and disseminate relevant clinical information. Candidates should possess an advanced degree and have at least 3-4 years of experience in medical affairs. The role offers a competitive salary ranging from $171,300 to $245,000, with inclusive market-leading benefits including paid time off, educational assistance programs, and retirement plans. #J-18808-Ljbffr

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 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.

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)

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.

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

SummaryJob 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. The Quality Assurance Manager has the responsibility of managing and developing the QA Team in Irvine, CA. The individual provides Quality Engineering/Systems leadership to support Operations and to drive continuous improvement while ensuring compliance to procedures and requirements. The daily tasks associated with the role are incoming quality control, manufacturing, materials management, labeling, and product disposition management along with maintenance of the quality system. Essential duties and responsibilities: Manages QA department and overall expectations pertaining to setting accurate schedules, costs and resources. Ensures department is adequately resourced and trained to perform jobs effectively. Directly supervises QA staff including mentoring and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary. Ensures delivery against QA department goals and objectives, i.e. meeting commitments and coordinating overall quality assurance schedule. Encourages a team environment, leads by example and demonstrates servant leadership skills. Prepares and maintains department budgets. Serves as a team member to provide quality engineering expertise to continuous improvement teams and manufacturing support. Implements ongoing quality improvement processes working with interdepartmental teams. Develops project schedules and resource allocation models for QA related projects and other activities to support project teams. Provides effective communication regarding issues, objectives, initiatives and performance to plan. Develops inspection and process control procedures, processes through document control and provides training for the procedures. Develops metrics to identify and prioritize activities pertinent to process control, risk reduction, and cost improvement. Manages non-conformance data and provides oversight for corrections, trending, tracking, external communications, closure and reporting. Develops, tracks, trends, reports and maintains Quality Indicators to enhance quality of products and business performance. Facilitates communication and teamwork between R&D/NPD and Operations, towards the purpose of design transfer. Ensures conformance to change control requirements for process and production changes. Maintains compliance to FDA Quality System Regulations, ISO:13485 standards and other regulations, as applicable. Performs special assignments and other duties as assigned. Interfaces effectively with senior leadership. Supports internal and external audits/inspections. Prepares and implements facility policies and procedures relating to quality. Ensures alignment and compliance to Corporate, Segment, Business Unit, and Department procedures. Qualifications: Verbal communication skills and presentation skills: Ability to create and understands how to present information dependent upon the level of the audience. Technical writing skills: Creating reports, presentations, rework protocols, validation protocols, metrics, procedures, forms, flowcharts, quality plans, quality agreements, etc., and review and approve technical documentation, as required. Leadership skills: Prioritizing resources based on changing business needs. Budgeting skills: Ability to control costs while providing appropriate resources in order to maintain compliance posture while meeting business needs. Computer skills: Ability to create and manage technical documents, as needed; ability to use electronic communication, time management, ERP and EDMS systems. Knowledge of medical device regulation, industry or international standards. Ability to understand Organization, Corporate, Business Unit, and other Facilities Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Knowledge and demonstrated use of document control, training and time management practices and investigational techniques (e.g., CAPA, non-conformance, thresholds, fishbone, 5-Whys). Ability to interpret Regulations and Procedures. Extensive knowledge of quality systems and relationship to business, along with inspection, testing, product release, manufacturing processes and associated systems. Fundamental knowledge of validation principles. Understands basic applied statistics, statistical sampling plans, and statistical process control.. Ability to find opportunities for quality and cost improvements. Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understand team functions, leadership techniques and project management methodologies. Ability to effectively manage time and handle multiple task assignments. Ability to translate quality requirements into product specifications. EDUCATION and/or EXPERIENCE: Bachelor's degree or higher in Science, Engineering, Technology or related field. Minimum of seven (7) years' experience in quality engineering within medical device or pharmaceutical manufacturing. Two (2) plus years' supervisory experience. Class III medical device experience is required. Working knowledge of chemical and molecular processes. Experience with managing FDA audits. Thorough knowledge of regulations governing production, packaging, inspection (preferably incoming/final release), testing and warehousing. ASQ CQE certification preferred. 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. #LI-PRO Required Skills Optional Skills . Primary Work LocationUSA CA - Irvine NeomendAdditional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $126,600.00 - $208,900.00 USD Annual

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

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

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. I. Position Summary: The Head of Quality Assurance is accountable for overseeing all aspects of Quality Assurance within Ocular Therapeutix. This role involves the planning, development, and execution of QA policies, programs, and initiatives to ensure that all materials, parts, and products meet established quality standards. This role is also accountable for company compliance with all cGMP, GxP, and ICH governmental regulations. The Head of QA will set quality objectives, formulate strategic action plans, and establish audit and surveillance protocols and be accountable for overseeing the Quality Management System (QMS) and monitoring the entire production process to ensure compliance with the applicable regulatory requirements. The Head of QA will provide leadership and guidance to personnel within QA groups and serve to support and liaise with other Functional Areas. This is a critical position within the Quality Leadership Team (QLT) and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the VP, Global Head QA/QC. II. Principal Duties and Responsibilities include the following: Leadership & Strategy: Lead the development and implementation of QA strategies, ensuring alignment of the Organization's goals and regulatory requirements. Set quality objectives and create strategic action plans to achieve desired quality results. Lead, mentor, and develop a high-performing QA team, fostering a culture of excellence, innovation, and continuous improvement. Collaborate with cross-functional leaders to integrate quality considerations into all aspects of product development, manufacturing, and commercialization. Establish/monitor Key Performance Indicators (KPIs) to measure and enhance the effectiveness of Ocular's QMS and the performance of the QA Team. Oversee the development and implementation of quality policies, procedures, and training programs to ensure cGMP compliance and product quality. Provide guidance on quality risk management, change control, and CAPA (Corrective/Preventive Actions) processes. Participate in due diligence activities for potential partnerships, acquisitions, or expansion opportunities, assessing quality implications and integration challenges. Management: Directly manage an excellent team of QA professionals and provide strategic leadership to the QA Team for sustained QMS programs with a continuous focus on improvement. Prepare employee development plans and provide regular performance reviews. Quality Assurance Programs: Accountable for the creation and execution of comprehensive QA policies and programs. Accountable for ensuring all processes, testing protocols, and standards are rigorously followed to maintain product integrity. Participate in CCRB (Change Control Review Board) actions to review and approve all critical change control documents and approve verification and validation protocols and their corresponding final reports. Regulatory Compliance: Stay informed on industry standards and government regulations to ensure all company quality processes meet or exceed these requirements. Work closely with regulatory bodies to maintain compliance and support responses to Health Authorities as needed. Participate in the preparation, review and approval of CMC sections of regulatory filings. Incorporate QbD (Quality by Design) into development activities to ensure successful scale-up and commercialization capabilities. Audit & Surveillance: Provide guidance on quality investigations as needed for all development and commercial products. Accountable for the timely completion of CAPAs to ensure cGMP and GxP compliance. Accountable for the development and direct management of quality investigations of customer complaints, non-conforming materials and processes, CAPAs, and product quality related risk analysis. Accountable for the compliance of third-party suppliers with applicable government regulations. Ensure timely release of clinical and commercial product batches. Establish and direct audit and surveillance protocols to monitor the production process and initiate quality investigations as needed to ensure compliance. Training & Development: Accountable to enhance existing training programs, standards, tools, and methods to cultivate a culture of quality throughout Ocular. Ensure that all team members are adequately trained in applicable procedures. Oversee development of personnel within the Quality Organization. Continuous Improvement: Drive continuous improvement initiatives across all quality processes. Utilize data and analytics to identify areas for enhancement and implement solutions. Reporting & Communication: Serve as the primary point of contact for QA related inquiries. Provide timely and regular reports to Senior Management on product quality status, compliance issues, status of QA programs, quality improvement initiatives, and QMS operational status. III. Qualification Requirements: Bachelor's Degree in Life Sciences or related field. 15+ years of experience in the pharmaceutical industry with prior quality management experience. Experience working in a GxP setting (commercial and/or clinical). Expertise in QMS and compliance. Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others. Knowledge of electronic systems. Experience with external regulatory inspections (e.g., FDA). Excellent organizational skills and attention to Strong interpersonal, verbal and written communication Computer literacy, proficiency in MS Office, Excel, PowerPoint Salary Range$250,000-$270,000 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.

Job title: QA Specialist Department Division/Location: FLSA Status Quality Assurance Ontario, CA , USA Non-Exempt Position Reports To: Effective Date of Job description: Alternate Lourdes Gonzalez 7-16-2020 Lourdes Gonzalez POSITION SUMMARY A Quality Assurance Specialist performs any kind of testing and validation that will ensure food safety. The tasks will include support project efforts. This position will involves constant improvement of the operations processes. It will also operate as a member of the cross-departmental teams and projects if necessary. EDUCATION Elementary/Some High School High School/GED Post Secondary Education Bachelor's Degree/Master's Required Preferred Required Preferred Required Preferred Required Preferred Certifications: SQF Practitioner HACCP Required Preferred Required Preferred Required Preferred EXPERIENCE Years: 2-5 Special Focus of: Food Manufacturing SKILLS REQUIRED Detail-oriented individuals with analytical minds and strong communication skills. This position should demonstrate the following: Technical Skills - Understanding quality assurance as well as production technologies and systems is crucial in this role Computer Skills - Knowledge of Microsoft Office Suite programs, such as Word and PowerPoint, is necessary for QA specialists to produce documents, reports, and presentations Commercial Awareness - These specialists should be experts in industry standards impacting inspection and quality control techniques and procedures Communication Skills - Strong oral and written communication skills for making presentations and producing testing and quality assurance reports is necessary. Attention to Detail - The ability to detect issues from among many products and review every aspect of production operation calls for a keen eye for details. Team-Oriented - QA specialists work closely with quality control managers, production workers, quality engineers, inspectors, and other personnel Analytical Skills - Analyzing production processes and applying this skill to the inspection of products is central to this role Time Management - produce results in a timely manner. PRIMARY RESPONSABILITIES Deviation Analysis Support the analysis and corrective action of deviation that may come from process deviation, complaints, holds, etc. using root cause analysis techniques. Product and Raw Material Testing Support qualification of new product, raw materials and suppliers. Perform inspection on raw material and/or finished goods to check for defects and other product parameters to validate Plant internal programs and processes. Equipment Commissioning Support all tests related to new equipment commissioning and prepare report for further review. Process Validation Support validation plans for Plant's processes. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Prepare detailed reports based on results of validation and qualification tests. Collect and analyze production samples to support process validations. Analyze quality control test results and provide feedback and interpretation to production management or staff. Performs audits of the effectiveness of development processes and products and recommends improvements as necessary Work with upper Management to identify performance improvement opportunities by analyzing quality data and documentation. Documenting/Recording Information Entering data in the QA drive to maintaining information in electronic form to facilitate data analysis. Operations Procedures Support the development of new procedures for Operations that will improvements and/or minimize errors and defects in product. Support operations processes standardization. Continuous Improvement Download quality and production information form Aptean system and perform monthly reviews and targets. Support and/or develop QA test trends and as need. Training Support Plant training program by creating training material for Quality and Production and consequently employee training. Safety Participate in, and support all safety program elements, directed towards meeting the plant's TIR (Total Incident Rate) goal established each year. This includes safety training, inspections, incident investigations, incentive programs, and any other safety-related activities. Comply with all company policies and procedures including safety rules. Food Safety and Quality Adheres to all Food Safety/Quality SOP's Communicates any known or suspected Food Safety/ Quality issues to the Production Manager or Supervisor, Q.A. Department or Management. Attends Food Safety/Quality training sessions.

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

Qualifications 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 Quality Assurance. Responsible for organizing on-site quality supervision, managing quality-related investigations and CAPA execution, and organizing batch record review and product release activities. Ensure that production operations and related quality activities comply with GMP and company quality standards, safeguard product quality and compliance, and drive continuous improvement of the quality system and team capability. Essential Responsibilities On-Site Quality Oversight Plan, organize, and oversee on-site quality supervision activities to ensure GMP compliance and effective execution of procedures. Review and approve quality supervision documentation, ensuring timely identification, escalation, and resolution of quality issues. Review and assess original GMP records, including deviation investigations, change controls, and equipment malfunction documentation. Oversee and authorize in-process control (IPC) release activities in accordance with approved procedures. Quality Investigations and CAPA Management Establish, organize, and maintain compliant processes for quality investigations and CAPA execution. Provide technical oversight, guidance, and review of deviation and customer complaint investigations conducted by investigators. Ensure investigations and CAPAs are completed on time, thoroughly documented, and effectively closed. Monitor and track CAPA implementation and effectiveness to drive continuous improvement of the quality system. Batch Record Review and Product Release Establish and maintain procedures governing batch record review and product disposition. Ensure timely and thorough review of batch production and testing records, with prompt resolution of discrepancies. Organize and oversee product release activities, ensuring compliance with regulatory requirements while maintaining operational efficiency. Cross-Functional Quality Leadership Act as a primary Quality interface with Operations, Quality Control, and Engineering functions. Facilitate cross-functional resolution of quality issues and provide GMP guidance to support operations. Report quality metrics, deviation and CAPA trends, and improvement initiatives to management. Provide quality and compliance input for cross-functional projects and process improvement initiatives. Team Leadership and Resource Management Lead and manage on-site QA and Operations On-Site QA teams, defining roles, responsibilities, and performance expectations. Coach and develop team members to strengthen competencies in investigations, CAPA management, and GMP documentation. Assess workload and resource needs, adjusting staffing and priorities to ensure business and compliance requirements are met. Additional Responsibilities Audit and Inspection Support Support internal and external audits and regulatory inspections. Ensure timely development, implementation, and closure of corrective actions arising from audit and inspection findings. 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 plus years, minimum of 2 years in management. Preferred: 10+ years, minimum of 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!

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.