Quality Assurance Manager, Lot Disposition

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you'll 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 world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

In Plainville, MA, within the Viral Vector Services (VVS) division of Thermo Fisher Scientific, we provide Advanced Therapeutics. We support clients in all stages, from process development to commercial supply, and offer the necessary expertise and resources for innovative gene therapies.

Discover Impactful Work:

You will lead cross-functional teams, providing expertise in Quality and cGMP regulations for the US, EU, and other regions. This will ensure that Plainville consistently meets or surpasses product supply targets and maintains high levels of quality.

As a leader within the Quality team and the site, you will lead the Quality Assurance Lot Disposition group. With your excellent interpersonal skills you will ensure that Plainville has highly satisfied internal and external customers, and successful with regulatory inspections.

A Day in the Life:

• Responsible for leading a team of QA specialists to ensure Quality product within the facility.
• Implement robust business processes to support the timely lot disposition.
• Implement and maintain a Culture of Quality and drive Quality Maturity.
• Build and maintain expertise in the QA Lot Disposition team, including development of staff. Apply biologics manufacturing experience to ensure that all customer and regulatory expectations and requirements are met.
• Drive continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• People Development: Lead and motivate the team in the achievement of their objectives. Support the development of quality professionals. Promote quality awareness and dedication to quality across the unit.

Keys to Success:

Education

• BS degree required. Preferably in a Biological Science or related field.

Experience

• At least 6-8 years of related experience in the Quality Unit.
• Validated understanding of Quality procedures, processes and guidelines required.
• Experience in Batch Disposition required.
• Experience leading conversations with customers.

Knowledge, Skills, Abilities

• Extensive exposure to cGMP environment.
• Understanding of applicable regulatory requirements.
• Demonstrate excellent organization and time leadership skills.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.