Work Schedule
Standard (Mon-Fri)
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.
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
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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