Associate Director, Gps Stability

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The Associate Director Stability is responsible for stability product strategy and the oversight of product stability programs for commercial large molecules Drug Substances and Drug Products. Activities include: strategy development, program requirements, sample management, preparation, review and approval of stability reports and regulatory filings. The role also involves leading a high‑performance technical team, developing team members, and fostering company culture.

• Accountable for the stability commercial program for large molecules Drug Substances and Drug Products.
• Accountable for new product commercialization and providing support to sites or external manufacturing for new product launch.
• Serves as the stability representative on project teams covering post‑approval changes, designs and executes required pre‑market stability programs.
• Coordinates the annual commercial stability program for assigned products with the sample management group.
• Provides technical expertise to the stability team.
• Supports authoring stability sections of filing dossiers for post‑approval filings and responds to authority inquiries.
• Approves stability sections of filing dossiers, annual reports, product renewals, and Annual Product Stability Reviews.
• Supports OOT/OOS investigations, market action fact‑finding, and other investigations related to potential quality or capacity issues.
• Ensures stability procedures are consistent with site, department, and BMS group procedures.
• Leads OpEx initiatives to streamline and standardize stability program management.
• Supports health authorities in internal and external inspections.

• Leads the team and focuses on pipeline complexities to achieve milestones and objectives while providing technical oversight, mentorship, and coaching.
• Directs and influences multiple remote teams with a global mindset.
• Promotes a sense of team responsibility for group success, driving high commitment to business goals.
• Defines stability resources and oversees budget.
• Fosters a culture that demonstrates high capacity for execution in line with company values and behaviors.
• Provides ongoing performance assessments and development opportunities for team members.

• Minimum 10 years of relevant work experience, preferably in a pharmaceutical environment.
• Minimum 2 years of team management experience.
• Expert knowledge of stability ICH Guidelines (Q1A, Q5C) and related policies and guidance.
• In‑depth knowledge of cGMP regulations (21
  
  CFR) and their specific application to stability programs in a manufacturing facility.
• Expertise in US/EU/ROW requirements, corporate directives, and industry best practices.
• Strong understanding of Drug Substance and Drug Product manufacturing and analytical/microbiology methods.
• Significant experience authoring technical documents and critically reviewing investigations for quality solutions.
• Experience leading science‑based initiatives for complex problem resolution.
• Experience with health authority inspections.
• Excellent written and verbal communication skills.
• Leadership experience in team, conflict management, coaching, talent selection, development, decision‑making, relationship building, innovation management, and resource allocation.
• Advanced knowledge of…