QA Manager, Quality Systems

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.

The Quality Manager for APR (Annual Product Review, CPV (Continuous Process Verification) and quality systems will play a pivotal role in ensuring the compliance, quality, and continuous improvement of our pharmaceutical products through thorough and comprehensive annual reviews, process verification, documentation management and training management.

A day in the Life:

• Lead and provide day-to-day managerial support to a dynamic and impactful team of 15+ colleagues.
• Lead the APR process for all pharmaceutical products, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams, including Operations, Tech Services, Quality Assurance, Quality Control, Regulatory Affairs, and Engineering, to gather vital data for APR, CPV.
• Conduct in-depth analysis of manufacturing and quality control data to identify trends, discrepancies, and areas for improvement.
• Prepare detailed APR reports summarizing product quality, deviations, investigations, and any required corrective actions.
• Ensure timely submission of APR and CPV reports to clients and address any inquiries or requests for additional information.
• Identify and propose strategies for continuous improvement based on APR and CPV findings, aiming to enhance product quality and compliance.
• Provide guidance and training to staff involved in the APR and CPV process, fostering a culture of quality awareness and accountability.
• Manage the quality systems team, collaborate with cross-functional teams,

Education

• Bachelor’s degree in science or a related field preferred

Experience

• 6+ years of experience within the pharmaceutical industry.
• In-depth knowledge of regulatory requirements related to Annual Product Review, CPV and pharmaceutical documentation management systems (EDMS).

Knowledge, Skills, Abilities

• In-depth knowledge of regulatory requirements related to Annual Product Review, CPV and pharmaceutical quality systems.
• Strong analytical skills with the ability to interpret complex data and trends.
• Excellent communication and interpersonal skills to collaborate effectively across departments.
• Proven leadership abilities and experience in managing cross-functional teams.
• Understanding of Pharmaceutical Regulatory Requirements

#qualitycinci