Quality Manager

Work Schedule

Environmental Conditions

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.

Position is based at our Manati, Puerto Rico, site and will report to our Site Quality Head. The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

As part of the Quality Operations Team, you will resolve quality issues in manufacturing area and bring up as needed. Guide, review, and approve GMP documents. Assist in technology transfer of new products and provide validation mentorship. Perform routine quality walkthroughs. Participate in site inspection readiness and audits.

• Engage in client meetings and activities.

• Collaborate across functions to tackle problems and improve processes.

• Release final products and material components.

• Implement quality changes as part of CAPA.

• Manage the QA-Batch Record Review team to meet timelines.

• Oversee retention samples.

• Liaise with various departments to ensure regulatory compliance.

• Manage the Quality on the Floor team.

• Conduct internal Gembas for improvement opportunities.

• Support other departments in Quality Management.

• B.Sc. degree required, and M.Sc., or PhD in Natural Sciences or Engineering highly preferred.

• Additional qualifications in Quality Management or Quality Assurance are encouraged.

• Advanced knowledge of Quality Manufacturing Operations with at least 2 years of experience required.

• Supervisory and managerial experience with at least 5 years of experience.

• Knowledge of Quality Assurance for Pharmaceuticals (cGMP) is encouraged.

• Basic expertise in Oral Solid Dosages is helpful.

• Independent and structured working style.

• Strong interpersonal and teamwork skills.

• Expertise in Quality Assurance and Compliance.

• Knowledge of cGMP and FDA compliance.

• Strong communication, leadership, and organizational skills.

• Quality, regulatory, and production mindset with a focus on client service and contract manufacturing.

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.