Associate Manager, Quality Assurance
About The Position
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovation. The Associate Manager Quality Assurance has responsibility for a QA team implementing elements of the quality management system. The role involves ensuring internal and/or client processes, systems and/or projects are compliant and inspection ready. The Clinical Quality Assurance Supervisor manages and develops staff and ensures delivery of quality solutions in a collaborative cross-functional environment.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years)
- 1+ year of leadership responsibility
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Solid leadership and time management skills
- Knowledge of appropriate regional regulations and applicable global pharmaceutical industry guidelines
- For Lab QA Management, knowledge of analytical methodologies, instrumentation and method validation required
- Good verbal and written communication skills
- Demonstrated proficiency with regulations and guideline interpretation, proper documentation and QA departmental policies and procedures
- Detail oriented with ability to deal with multiple and changing priorities
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
Nice To Haves
- Understanding of Molecular Genomics and Flow Cytometry assays preferred
Responsibilities
- Manage the day-to-day operations of a QA team and provide oversight, development and performance management to staff to meet performance objectives
- Assess with supervisors priority of projects and monitor work assignments ensuring adequate resourcing to meet internal and client timelines and provide quality deliverables
- Assist senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits
- Evaluate issues and trends reported by QA staff and determine appropriate departmental interpretation. Identify issues that may require follow-up or improvement. Communicate findings to staff and senior management
- Participate in client and regulatory inspections in order to provide information regarding the QA program and facilitate responses
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
