Senior Director – Competitive Compliance – Corporate Quality

Senior Director – Competitive Compliance – Corporate Quality

Requirements

• Minimum of a bachelor’s degree in scientific discipline.
• 15 plus years’ experience in the pharmaceutical industry.
• Thorough understanding of regulatory requirements across multiple modalities inclusive of GMP, GDP and IT/Data Integrity Requirements.
• Profound understanding of international GxP regulations and policies setting processes of major regulatory agencies (e.g., US FDA, EU, WHO).
• Quality operational experience to ensure understanding of key business quality and compliance drivers of the Pharmaceutical Industry.
• Strong communication, negotiation, problem solving, and interpersonal skills.
• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.
• Demonstrated change agility and leading others through change and ambiguity.
• Ability to provide innovative ideas or alternatives that create.
• High organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
• Demonstrated ability to work effectively in a matrix environment and drive results through ‘influence’ as well as direct management.
• Demonstrated Enterprise mindset to be able to think and act across functions and divisions.

Responsibilities

• Responsible for development of risk-based process for assessment of sites, suppliers and contract providers across all modalities and vendor types ensuring inspection readiness strategies and risk mitigation across the enterprise.
• Responsible for the execution of strategic audit plan and identification of emerging risk.
• Development of Inspection Readiness strategy that provides standardized end-to-end approach to inspection preparedness that can be leveraged by the BMS network.
• Collaborate to Identify emerging internal and external compliance indicators to proactively inform inspection readiness strategy.
• Partners with business to accommodate ad-hoc audits based on performance or changes in business needs.
• Responsible for management of risk-based audit program across all modalities and vendor types.
• Partners with business units and functions to drive remediations of audit outcomes with a lens towards enterprise performance and patient supply.
• Serves as consultancy to sites/functions with regulatory inspections including pre-inspection readiness as well as regulatory inspection responses for complex compliance matters.
• Assist with regulatory notifications, including assuring appropriate and consistent standards are in place.
• Works closely with legal to ensure robust and appropriate communications with external regulators globally.
• Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
• Continuous improvement across R&D and GPS quality metrics defined by GxP requirements.

Preferred Qualifications

No preferred qualifications provided.