Sr Mgr Product Quality Integrator

Main 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.
• 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.
• Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of medium risk, uncertainty and ambiguity.

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.
• Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering.
• Knowledge in cGMP standards, policies and procedures.

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