PDS Quality Operations Team Leader

Work Schedule

Flex 12 hr shift/days

Environmental Conditions

Office

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.

DESCRIPTION:
Join a quality leadership role at Thermo Fisher Scientific where you'll ensure excellence in our quality assurance operations while enabling life-changing science. As Team Leader, QA, you'll guide a team ensuring the highest standards of product quality, regulatory compliance, and customer satisfaction. You'll oversee critical quality systems including batch record review, deviation management, document control, and quality investigations while supporting a culture of continuous improvement. This role offers the opportunity to make a meaningful impact by safeguarding product quality and patient safety through effective team leadership, process optimization, and collaboration.

REQUIREMENTS:
• Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in pharmaceutical/biotechnology quality assurance or manufacturing
• Preferred Fields of Study: Chemistry, Biology, Pharmacy, Pharmaceutical Chemistry/Technology (CTF), or related scientific field
• 1+ years of leadership/supervisory experience managing direct reports
• Expert knowledge of cGMP regulations, FDA, EMA and ICH guidelines
• Strong understanding of quality management systems and risk-based approaches
• Demonstrated ability to lead batch record review and quality investigations
• Experience with quality documentation systems and electronic QMS platforms
• Proficiency in data analysis, metrics tracking and trending
• Advanced knowledge of deviation management and CAPA processes
• Strong project management and organizational skills
• Excellent verbal and written communication abilities
• Demonstrated success in cross-functional collaboration
• Proficient in Microsoft Office suite and quality systems (TrackWise, SAP, etc.)
• Strong attention to detail and analytical problem-solving skills
• Must be able to work in cleanroom environments as needed
• May require occasional weekend/holiday coverage
• English language proficiency required, additional languages beneficial
• Experience with client/regulatory audits preferred