ASSOCIATE DIRECTOR, GMS STABILITY

Role Summary

The Associate Director Stability is responsible for stability product strategy and oversight of product stability programs for commercial large molecules Drug Substances and Drug Products. Activities include those associated with product stability strategy, stability program requirements, stability sample management, preparation, review and approval of stability reports and regulatory filings. The Associate Director is responsible for leading high-performance technical team, developing team and fostering company culture.

Responsibilities

• The Associate Director Stability is accountable for the stability commercial program for large molecules Drug Substances and Drug Products.
• Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization.
• Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change.
• Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group.
• Provides technical expertise to the stability team.
• Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries.
• Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews.
• Provide support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues.
• Accountable for stability procedures and ensures consistency with site department and BMS groups procedures.
• Leads OpEx initiatives to streamline and standardize management of stability programs.
• Supports health authorities' inspection internal and external.

Qualifications

• 10 years of relevant work experience required, preferably in a pharmaceutical environment.
• 2 years' experience as team manager.
• Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
• Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
• Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.
• Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles.
• Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions.
• Significant experience on health authorities' inspections in front room.
• Excellent written and verbal communication skills.
• Leadership experience Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
• Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).

Skills

• Stability program management
• Regulatory filing support
• Cross-functional collaboration
• Technical leadership
• Quality systems and compliance

Education

• Not specified