Senior Specialist, Quality Assurance
About The Position
The Senior Specialist, Clinical Supplies Quality, Global Development Quality supports the clinical supply chain for clinical development programs, ensuring reliable availability, quality, and regulatory compliance of clinical supplies. The role supports US quality operations and disposition, global distribution planning and management, and acquisition integration. The position works closely with Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, External Development & Manufacturing, Global Clinical Trial Operations, and other clinical supply chain functions. It addresses high-impact situations to help prevent disruptions to the company's clinical development portfolio and pipeline. The incumbent provides technical and quality expertise in clinical supply operations and integration, medical devices and combination products, and new technologies. The role develops and executes quality and stakeholder strategies and improvement initiatives, evaluates and dispositions clinical supply materials, supports investigations of deviations and significant quality events, and identifies and resolves trends or compliance gaps affecting quality and supply reliability.
Requirements
- Bachelor’s degree in a scientific discipline and 5 or more years of relevant pharmaceutical industry or GMP-related experience, including technical, engineering, quality, or operations experience; or an advanced degree and 6 or more years of relevant experience.
- Familiarity with batch disposition or release activities.
- Prior experience reviewing and approving investigations, supporting deviation management, and managing Corrective/Preventative Actions (CAPAs).
- In-depth working knowledge of cGMPs and regulatory requirements applicable to pharmaceuticals or a related area.
- Strong technical expertise in R&D activities related to clinical supplies.
- Strong compliance knowledge and ability to interpret and apply cGMPs in an R&D environment.
- Demonstrated experience working with external parties and stakeholders, and ability to influence subject matter experts and senior leaders.
- Knowledge of continuous improvement methodologies and ability to manage complex cross-functional initiatives.
- Demonstrated leadership in strategy development and deployment, with tangible delivered benefits.
- Strong oral and written communication, presentation, interpersonal, conflict-resolution, and teamwork skills.
- Attention to detail, flexibility, and awareness of production and quality-control problems.
Nice To Haves
- Experience with medical devices, combination products, and new technologies.
- Ability to independently manage multiple priorities and projects.
- Ability to lead and support cross-functional, multi-level teams, including senior management representatives.
- Demonstrated analytical and problem-solving skills.
- Knowledge of Lean Six Sigma and project management.
- Knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel, and Word.
Responsibilities
- Provide technical and quality expertise regarding clinical supply operations and integration, medical devices and combination products, and new technologies.
- Develop and execute quality and stakeholder strategies and improvement initiatives aligned with business objectives, streamlining processes and procedures and leveraging technology.
- Evaluate and disposition clinical supply materials to ensure they were produced in compliance with company policies, procedures, and applicable regulations.
- Coordinate or support investigations of deviations and significant quality events.
- Identify trends and potential compliance gaps and lead resolution of significant issues affecting quality and clinical supply reliability.
- Support US quality operations and disposition, global distribution planning and management, and acquisition integration.
- Collaborate with stakeholder groups and functions across the clinical supply chain to help prevent disruptions to clinical development programs.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Annual bonus eligibility
- Long-term incentive, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Senior
