- Provide strategy, oversight and leadership in support of the APQR run the business activities including document authoring, coordination of review and comments resolution, approval, for both site and End to End APQRs.
- Ensure execution and performance of run the business and strategic initiatives associated to APQR s continuously improve to meet compliance needs and business priorities.
- Support health and performance of APQR program in compliance with procedural guidelines and requirements.
- Ensure on time execution of the APQR program in accordance with the published schedule.
- Manage stakeholder needs in balance to priorities and execution of the APQR program, through management of the APQR team
- Manage events associated to findings of compliance gaps, inspectional observations and deviation from global processes.
- Liaison with the business as the subject-matter expert to ensure accurate APQR content and compliance with health authority regulations and expectations and BMS procedures.
- Provide leadership and coaching in relation to contemporary knowledge of current industry trends, standards, and methodologies as it relates to APQR.
- Manage risk and uncertainty, and to anticipate the need for and implement contingency plans to ensure on time delivery of APQR documents.
- Provide strategy, oversight and leadership in support of the APMC run the business activities including regulatory filing and change control reference data updates, master data maintenance, and data reviews/approvals for products released in SAP Batch Release Hub.
- Lead team to meet goals while resolving complex issues
- Develop, adjust, and monitor key performance indicators to identify and mitigate risk to business objectives.
- Monitor trends to develop continuous improvement objectives and revised contingency plans (as required)
- Collect metrics to identify trends and take appropriate action.
- Communicate up to date status to impacted business units
Qualifications & Experience
- Demonstrated quality leadership, organization, and communication skills.
- Ability to lead a team in a global matrix environment.
- Understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes, preferred.
- Experience in a GMP Quality role required.
- Working knowledge of conducting and compiling APQRs.
- Prior experience with navigating multiple Quality Management systems.
- Experience with commercial change control processes.
- Demonstrated tactical thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
- Ability to build strong relationships across the organization by being transparent, reliable, and delivering on commitments.
- Ability to provide innovative ideas, align and make decisions balancing speed, quality, and risk.
- Education/Experience/ Licenses/Certifications: Minimum of a Bachelor s degree in a Natural Science, Pharmacy, Engineering, or other Healthcare-related field.
- Minimum 10+ years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated leadership in Quality Compliance or Operations preferred.
- Minimum 2 + years of people management experience
- Requires availability during core US and EU hours
- Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, including the ability to deliver clear and articulate presentations
With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
