Sr Mgr Product Quality Integrator

About the role

The Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics is responsible for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow for an assigned group of large molecules (biological) products.

Responsibilities

• Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams.
• Serves as liaison between VCT and Analytical group.
• Serves as the single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved.
• Quality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings.
• Approves filings and questions for secondary filings.
• Supports PAI and agency audits for the product(s) assigned.
• Defines and oversees the necessary QA resources for global and local QA of his or her assigned products.
• Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
• Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
• Ensures product quality development through Launch and Grow stage.
• Supports the sites, represents the sites on CMC and VC teams.
• Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
• Ensures patients get the right quality products.
• Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
• Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
• Supports preparation of the criticality analysis per schedule.
• Safeguards complaints are well managed, issues are understood, and addressed as necessary.
• Participates in product safety management teams to present Product Quality Complaints trends and topics.
• Coordinates and/or owns complaints trend signal investigations.
• Presents project updates to QM for Global Quality alignment.
• Escalates issues when appropriate.
• Works with the cross-functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.
• Participates and actively engages on IMTs.
• Supports field/recalls as needed.
• Drives Decision making and Problem Solving:
• Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
• Gives input to the development of new strategies and implements and deploys strategies.
• Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production.

Qualifications

• A minimum of a bachelor’s degree (or University equivalent) with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration.
• A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry.
• Knowledge in cGMP standards, policies and procedures.
• Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering.
• Quickly assimilates new technologies, performs risk assessment and develops action plans.

Preferred Skills

• Business Alignment
• Collaboration
• Compliance Management
• Fact-Based Decision Making
• Good Manufacturing Practices (GMP)
• ISO 9001
• Mentorship
• Organizing
• Quality Auditing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Regulatory Environment
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Technical Credibility