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Life Technologies - Swedesboro, NJ
posted about 2 months ago
About the position
The Senior Quality Manager at Thermo Fisher Scientific will lead the Quality function within the Clinical Trials Division, ensuring compliance with customer and regulatory requirements. This role involves developing and maintaining quality assurance and control processes, promoting a safe work environment, and providing strategic insights to improve logistics services. The position requires collaboration across global teams to enhance quality management systems and drive continuous improvement initiatives.
Responsibilities
- Promote and facilitate a safe work environment for all employees.
- Strengthen and improve the Quality Management System by coordinating various areas such as Distribution Quality Assurance, auditing, document management, and CAPA resolution.
- Lead the operational quality function for the Clinical Ancillary business in North America.
- Provide quality oversight and leadership for the Transportation and Logistics functions within the Pharma Services Group.
- Develop solutions for the logistics business to improve existing services and expand to new markets.
- Cultivate a partnership with Operations to drive a culture of continuous development of quality processes.
- Apply a decision-making approach to Quality issues that leads to well-rounded Root Cause and Corrective Action.
- Define metrics that matter for quality and the operational teams.
- Deliver mentorship for product-related investigations, deviations, change controls, and validation reports.
- Serve as the main contact for significant quality issues and advise senior management.
- Participate, lead, and drive Continuous Improvement events by encouraging employee engagement.
- Work as a leader to support the Quality team for overall quality management.
Requirements
- Bachelor's Degree in a science-related field; Master's degree preferred.
- 5+ years management experience preferred.
- Experience leading conversations with customers and auditors preferred.
- Practical application experience in continuous improvement methodologies.
- Proven understanding of GMP/GDP principles in a pharmaceutical distribution environment.
- Experience leading and hosting audit executions for regulatory and customer inspections.
- Proficient in state licensing regulations.
Nice-to-haves
- Excellent interpersonal skills.
- Ability to influence others and lead significant change.
- Exhibit drive, creativity, collaboration, assertiveness, good judgment, and decision making.
- Good verbal and written communication skills.
- Critical thinker and problem solver.
- High attention to detail.
Benefits
- Competitive remuneration
- Annual incentive plan bonus scheme
- Healthcare
- Range of employee benefits
- Career and development prospects
- Innovative company culture
