PDS Quality Operations Team Leader

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll ensure excellence in our quality assurance operations while enabling life-changing science. As Team Leader QA youll guide a team ensuring the highest standards of product quality regulatory compliance and customer satisfaction. Youll 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 Bachelors 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