Senior Manager - Quality Compliance

Senior Manager, Quality Systems

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

We are seeking a strategic and experienced Senior Manager, Quality Systems to lead our global internal audit and compliance programs across multiple divisions and global sites. This role is pivotal in ensuring consistent adherence to external laws, regulations, guidance, and standards (LRGs: Local and Regional Governments Standards), while driving continuous improvement in quality systems, regulatory compliance, and operational excellence.

You will lead a team of professionals responsible for internal audits, investigations, audit execution, and quality system enhancements. This role is pivotal in mitigating risk, supporting external audits, and fostering a culture of compliance and performance across Abbott's global operations. This position can be based in either Pleasanton, CA, Sylmar, CA, or Minnetonka, MN.

What You'll Work On

• Lead and manage the Divisional Global Quality and Compliance internal audit team, ensuring timely and thorough planning, execution, and closure of audit activities.
• Oversee internal and provide business support to external audit across multiple sites and geographies.
• Establish, implement, and maintain the effectiveness of the quality system, including the quality policy, quality plan, and supporting organizational structure.
• Provide strategic direction and long-term planning to meet divisional and site quality goals.
• Coordinate and lead a broad, multi-disciplinary work unit across multiple sites and product families.
• Ensure achievement of compliance, financial, and performance goals for large-scale, strategic projects and QA initiatives.
• Develop and enforce operating policies and procedures that align with company-wide standards and regulatory requirements.
• Monitor and adjust departmental budgets, schedules, and performance metrics to meet organizational objectives.
• Evaluate investigation findings and ensure documentation meets "Right First-Time" standards for senior management review.
• Represent Abbott in interactions with regulatory bodies and standards organizations.
• Foster a diverse, inclusive, and high-performing team culture through coaching, mentoring, and talent development.

Accountability & Scope

• Responsible for ensuring executive management is informed of compliance risks and regulatory requirements.
• Make critical technical decisions that directly impact product quality and business continuity.
• Assignments are objective-oriented and reviewed based on alignment with organizational goals and timelines.
• Consequences of erroneous decisions may include significant delays, resource expenditures, and potential business impact.

Required Qualifications

• Bachelor's degree in a scientific or technical discipline or an equivalent combination of education and work experience.
• Master's Degree Preferred
• Must have demonstrated solid knowledge and experience in the discipline.
• Leadership experience is required.
• Considered a Subject Matter Expert and key contributor to initiatives.
• Leader and key contributor to initiatives and advancement of the Quality organization.
• Emerging Leader. Demonstrates strong leadership competencies.
• Makes decisions and charts course through careful evaluation of risks and benefits with limited information in conjunction with Director.
• Builds/drives relationships and teamwork within team and across functions with professional demeanor.
• 7-10 years of experience in function or related field. 4-6 years of direct supervisor experience.

Preferred Qualifications

• Master's degree
• Experience in Quality Assurance, Regulatory Compliance, or related roles within the medical device.
• Strong knowledge of global regulatory standards (e.g., 21 CFR 820, 210/211, Part 11, ISO 13485, ISO 14971, MDSAP (Health Canada, ANVISA, TGA, PMDA/MHLW), EU MDR (2017/745), UDI).
• Proven leadership experience managing technical teams and complex audit programs.
• Excellent communication, analytical, written, and decision-making skills.
• Experience in a corporate/divisional quality or regulatory role with cross-functional influence.
• Experience managing global audit programs and working with international regulatory bodies.
• Familiarity with enterprise-level quality systems and digital compliance tools.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives.