Associate Manager, Quality Assurance (GMP)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office

Job Description

This is a hybrid role based at our GMP Laboratory in Middleton, WI. The onsite expectations for this role are ~3 days per week.

We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States.

Must be able to pass a comprehensive background check, which includes a drug screening.

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 innovations.

Discover Impactful Work:

The Associate QA Manager provides frontline leadership for junior QA Auditors and supports continuity of operations through resourcing, training, issue escalation, and staff development. This role oversees the quality of data and reports generated by GMP laboratory support functions, including equipment and software validation (IQ/OQ/PQ) documentation, instrument maintenance and calibration records, and facility qualification documentation. The Associate QA Manager also performs hands-on operational work within Support QA, Records Management, and other assigned areas as needed to maintain business continuity, support priority workflows, resolve escalations, and model expected standards for staff.

What You'll Do:• 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

Education & Experience:• 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 5+ years).• 1+ year of leadership responsibilityIn 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.

Knowledge, Skills, Abilities:• 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

Working Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.