Senior Manager, Global Regulatory Compliance

About the role:

The purpose of this role is to provide strong leadership & stewardship of the GRC audit team and internal audit process & Community of Practice.

The GRC Manager will work as part of a broad, global team within the Global Quality system and particularly with all site and divisional Quality leadership to identify any gaps in compliance with internal and external requirements.

The Global Regulatory Compliance Manager will create a culture of compliance and facilitate adherence to the Company Quality System and all appropriate regulations that the Company follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.

Locations:  Minnesota | California | Massachusetts | Indiana

Responsibilities will include:

• Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule.
• Partner with Quality leaders across the Company network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data-driven, risk-based audit schedule.
• Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
• Act as the sub-process steward for the global Internal Audit process.
• Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice.
• Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable to the assigned area for potential impact to the Company and initiate projects, as needed, to ensure continued compliance.
• Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.
• Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.
• Act as a CAPA owner for corrective actions necessary to improve the global processes.
• Champion departmental or cross-functional quality initiatives.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Required qualifications:

• Minimum of Bachelor’s degree in relevant field
• Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing
• Understanding of regulations and standards applicable to the Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution
• Ability to travel up to 25 – 30% domestically and internationally

Preferred qualifications:

• Advanced degree
• Pharmaceutical experience
• Digital product ownership and/or IT project experience
• Strong analytical and communication skills