Senior Quality Systems Manager

Boston Scientific Gruppe; Marlborough (MA); Hybrid; USD 127,000 - 243,000; Full time

Job summary

A leading global medical device company based in Marlborough, MA is seeking a Global Regulatory Compliance Senior Manager. This role requires strong leadership in managing the GRC audit team and ensuring compliance with regulations. Candidates should possess at least a Bachelor’s degree and 10 years of experience in Medical Device Quality Systems, with skills in auditing and regulatory processes. The position offers a salary range of $127,900 to $243,000 and follows a hybrid work model.

Qualifications

• Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing.
• Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Demonstrated inclusive leadership skills.

Responsibilities

• Manage, coach, and develop a team of quality system auditors.
• Partner with Quality leaders across the BSC network to ensure a high level of compliance.
• Lead the development and ownership of the strategic process roadmap.

Skills

Leadership

Regulatory Compliance

Quality Systems Auditing

Analytical Skills

Communication Skills

Education

Bachelor’s degree in relevant field

Job description

Global Regulatory Compliance Senior Manager

Onsite Location: Marlborough, MA, US, 01752

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. Here, you’ll be supported in progressing – whatever your ambitions.

About the role: Boston Scientific is seeking Global Regulatory Compliance Senior Manager & Internal Audit Quality Steward for its Global Quality Systems group. 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 BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your 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 BSC 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 BSC and initiate projects, as needed, to ensure continued compliance.
• Facilitate external audits through leadership in audit front rooms, back rooms, training for SMEs, 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 BSC 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

Requisition ID: 614961

Salary range: Minimum $127,900 – Maximum $243,000

The anticipated compensation and benefits offered by Boston Scientific will vary based on location and other factors. Compensation will be commensurate with experience and training. Boston Scientific is an equal opportunity employer.