Associate Director Quality Assurance Third Party Quality Management - Hybrid

Quality Assurance Specialist

The mission of Quality Assurance is to safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high-quality data and clinical supplies.

Working in the Finished Goods Platform TPQM (Third Party Quality Management) department within our Research & Development Division. You will be responsible for serving as the quality representative for and providing quality oversight of contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our Company.

Key responsibilities include:

• Act as a Lead Quality Liaison for the Quality Oversight of External Entities/CMOs.
• Manage the quality oversight of nominated Third-Party Vendors in the Clinical Finished Goods (FG) Platform.
• Lead internal contractor related issue investigation and resolution teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, participating in contractor GMP audits as a Subject Matter Expert, development and creation of contractor related metrics, conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform.

The position will be heavily involved in close collaboration with external contractor quality and technical personnel. Internally interacting closely with Quality Disposition, Pharmaceutical Research/Development and Procurement on strategic objectives-utilizing external contractors including GMP qualification as well as site/project selection.

Additionally, you would lead on projects related to quality oversight of vendors such as helping to develop key quality performance metrics. Serving as the bridge between R&D and Commercialization activities developing strong working relationships with commercial external quality management personnel. In the position you would be the key quality representatives attending and contributing at oversight and business review meetings with members from our company and contractor personnel to discuss projects and quality compliance together with overall performance topics.

In addition to the job specific responsibilities discussed above, you would be expected to independently execute the following:

• Serve as a Subject Matter Expert managing and investigating significant and complex quality events for external contractors. Leading cross-functional teams related to these events.
• Responsible for approval and assessment of; CMO Quality Events, Audit CAPs, Change Controls.
• Support of the Clinical Supply Chain for our Company's portfolio, specifically in terms of assuring the reliable availability, quality, and regulatory compliance of clinical supplies produced.
• Lead projects in a matrix management environment.
• Engage in strategic planning across the Quality Unit.
• Make independent decisions and act with authority to carry out required actions.
• Identify and lead implementation of Contractor and Supplier System improvements. Including trends and/or potential compliance gaps and proactively leads the resolution of adverse trends or significant issues in External Entities.
• Lead others in a matrix/management environment coaches, mentors and develops colleagues in areas of expertise including being an effective team player.
• Lead communication, and serve as the quality spokesperson, on a variety of quality or compliance-related issues with both internal stakeholders and external External Entities.
• Interpret complex regulatory requirements for various audiences, including source area management, and facilitates communication of these requirements across stakeholders. Reviews draft policy and standards.
• Communicate with senior management within our company and the contractor organization. Facilitates and/or prepares cross-functional management presentations.
• Demonstrated time management skills, effectively prioritize and manage conflicting priorities.

Education Minimum Requirement:

• Bachelor's Degree in: Pharmacy, Biology, Engineering, Chemistry or related field

Required Experience and Skills:

• At a minimum this position requires a bachelor's degree with a minimum of ten (10) + years of relevant experience within the pharmaceutical industry or Advanced Degree with a minimum of eight (8) + years relevant experience.
• Strong scientific/ technical knowledge and experience in R&D activities, coupled with the ability to interact with scientific subject matter experts on various initiatives and resolution of issues in the following areas:
• Clinical Packaging and Labelling,
• Distribution of clinical supplies and
• Dispositioning experience.

Preferred Skills and Experience:

• Leadership and good communication skills (oral and written) effectively with different colleagues/ groups
• Experience in quality disposition and or final batch release.
• Strong compliance knowledge of regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment, especially related to Investigational Medical Products, Finished Goods and Packaging.
• Demonstrated Strategic Project Development and time management skills, ability to conduct well defined projects within discipline or area of expertise.
• Strong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiatives.
• Ability to independently interact with regulatory officials and external auditing parties.
• Possess deep drug development knowledge; demonstrated ability to facilitate training and learning in colleagues and apply knowledge to enhance the drug development process.
• Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation
• Strongly developed cross-functional teamwork, collaboration and negotiation skills

Required Skills:

Audit Management, Batch Releases, Compliance Investigations, Deviation Management, Good Manufacturing Practices (GMP), Project Leadership, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance

Preferred Skills:

Cross-Functional Teamwork, Drug Development, Leadership, Matrix Management, Quality Assurance (QA), Supply Chain