Quality Director, Single Use Division Flexible Operations Sites

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

GROUP/DIVISION SUMMARY

The Head of Quality leads all aspects of operations in the Flexible Solutions department of our Single Use Technology Division (SUD) offering modern single-use technologies that empower our clients to speed up biological manufacturing procedures encouraging adaptability and improving operational agility in both upstream and downstream workflows.

POSITION SUMMARY

The Quality Director for the Single Use Division (SUD) Flexible Operations Sites is responsible for leading and advancing the quality strategy culture compliance and operational excellence across multiple manufacturing and operations sites supporting flexible single-use technologies and products. This role provides strategic and operational leadership to ensure products and processes consistently meet customer regulatory and company requirements while driving continuous improvement business performance and a culture of quality throughout the organization.

Key Responsibilities:

Quality Leadership & Strategy:

• Establish and implement the quality strategy for Flexible Operations Sites aligned with divisional and enterprise objectives.

• Foster a proactive quality culture emphasizing compliance continuous improvement customer focus and operational excellence.

• Lead and mentor site quality leadership teams building organizational capability and succession planning.

• Utilize performance metrics and quality objectives to drive accountability and measurable business outcomes.

• Serve as the primary quality escalation point for critical site customer and regulatory issues.

• Lead coach and develop high-performing quality teams across multiple locations.

Quality Systems:

• Ensure compliance with applicable global regulatory requirements industry standards and internal quality management systems.

• Maintain inspection readiness across all assigned sites including support for customer notified body and regulatory agency audits.

• Oversee effectiveness of Flexible site quality systems including:

  • CAPA Change control Nonconformance management Complaint handling Document control Training compliance Risk management and Validation activities

• Drive harmonization and standardization of quality processes across sites.

Operational Quality Excellence:

• Lead initiatives to reduce cost of poor quality and improve operational efficiency.

• Utilize data analytics and quality metrics to identify trends risks and improvement opportunities.

• Support product transfers capacity expansions and new product introductions with appropriate quality oversight.

• Ensure robust investigation practices and timely resolution of deviations and customer concerns.

• Build strong customer relationships through responsiveness transparency and quality performance.

Qualifications:

Education & Experience:

• Bachelors degree in Engineering Life Sciences Chemistry Quality or related technical discipline required.

• Minimum 1215 years of progressive quality leadership experience within regulated manufacturing environments.

• Minimum 5 years of leadership responsibility across multiple sites or complex manufacturing operations.

• Experience in bioprocessing medical device pharmaceutical life sciences or single-use technologies preferred.

• Strong knowledge of applicable regulations and standards including ISO 9001 ISO 13485 GMP and FDA requirements.

• Technical & Leadership Competencies

• Demonstrated success leading quality organizations in high-growth manufacturing environments.

• Strong strategic thinking and business acumen.

• Proven ability to influence executive leadership and cross-functional stakeholders.

• Expertise in quality systems risk management root cause analysis and continuous improvement methodologies.

• Strong communication presentation and organizational leadership skills.

• Ability to manage complexity and drive alignment across geographically dispersed teams

Key Success Metrics:

• Regulatory and customer audit outcomes

• Improvement in quality metrics cost of poor quality and customer satisfaction

• CAPA effectiveness and closure performance

• Employee engagement and talent development

• Standardization and harmonization of quality systems across sites

• Successful support of business growth and operational scalability

Leadership Expectations:

• Demonstrate strong ethical leadership and integrity.

• Build trust through collaboration accountability and transparency.

• Drive results while balancing quality compliance delivery and customer expectations.

• Operate effectively in a fast-paced matrixed global organization

Travel Requirements:

• Travel up to 25% domestically and internationally as required.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Director