Reporting to the Director of Quality Assurance, this role will be critical in supporting the growing needs of our Internal Manufacturing and Analytical functions. The Associate Director of Quality will build and lead a team of quality professionals responsible for providing quality oversight of Internal Manufacturing activities which will include batch record review, analytical data review, lot disposition and status changes, support the raw material program and collaborate with CMO management and packaging and labeling teams. This also includes collaborating with External Manufacturing Management to support investigations, CAPA’s and transfer activities. This role will also support PPQ and PAI readiness activities which includes providing quality guidance and support.
A critical part of this role is to expand quality operations oversight during manufacturing operations which includes collaborating and supporting the Quality teams to ensure clinical supply needs are met. The role is also expected to enable transparency and data driven decision making through the development of KPI's and reporting metrics.
- Lead a team of QA professionals to perform and support
- Batch record reviews during manufacturing operations
- Provide quality oversight on the manufacturing floor
- Lot disposition and status changes
- Deviation investigations and resolution
- Change controls
- Attend and participate in all Quality team and leadership meetings.
- Contributes to annual Talent Management activities: workforce planning, hiring, goal- setting, succession planning, career development and performance management
- Deep understanding of interconnectedness of operations and able to drive/influence trade-off decisions regarding the allocation of limited resources
Strategic Decision Making
- Sets department level strategy, ensuring alignment with overall division and company objectives. May contribute to department-level decisions on projects.
Support of daily tasks
- Perform reviews of internal and external batch documentation, records and reports.
- Review QC data generated as to the acceptance to established product specifications.
- Perform lot disposition activities for intermediate and final batches.
- Partner with members of QA, QC and Manufacturing in batch production activities providing subject matter expertise of general quality items.
- Partner with internal partners on change controls, investigations and CAPA(s).
- Perform review of document revisions for internal Manufacturing and Quality groups.
- Provide guidance and support with resolution of investigations, CAPA and Change Control impacting product disposition.
- Provides quality guidance and support for manufacturing and quality projects and programs, ensuring compliance with relevant GxP regulations and internal policies.
- Assist with the resolution of internal audit observations for internal manufacturing and quality teams.
- Responsible for escalation and resolution of significant quality deficiencies identified in the production process.
- Assist in the authoring and review of SOPs and applicable policies.
- Collaborate with Quality teams on streamlining and improving quality processes.
- Other duties as assigned.
- Minimum 10 years of well-rounded Quality experience in the pharmaceutical or biotechnology industry.
- Minimum 3-6 years experience of people management.
- Demonstrated ability building and leading quality teams with an emphasis on cross-collaboration with improved levels of quality compliance.
- Experience in FDA pre-approval inspection activities (PAI Readiness).
- Experience participating in regulatory audits.
- Experience supporting Process Performance Qualification (PPQ) activities and product transfers.
- Experience in performing and supporting deviation investigations and developing appropriate CAPA activities.
- Bachelor of Science degree or equivalent in life sciences or engineering.
- Experience in providing quality oversight during internal and external manufacturing activities.
- Experience working in cross functional teams and managing the relationships and expectations of several key stakeholders.