Director Sterility Assurance Environmental Monitoring QA Lab Oversight
Director Sterility Assurance Environmental Monitoring QA Lab Oversight
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Laboratory Setting Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue exceeding $30 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 improving patient diagnostics and therapies or increasing productivity in their laboratories we are here to support them.
The Drug Product Division North America (DPDNA) 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.
The Director of Sterility Assurance Environmental Monitoring & QA Lab Oversight leads a team that ensures product sterility and quality through effective quality assurance laboratory oversight and comprehensive sterility assurance programs.
Key Responsibilities:
- Develop implement and maintain sterility assurance programs to ensure the sterility of products throughout the manufacturing process and drive sitewide harmonization.
- Lead the design validation and monitoring of sterilization processes.
- Ensure compliance with relevant regulatory guidelines including FDA EMA and ISO standards.
- Provide strategic direction and oversight for the Quality Assurance laboratory ensuring accurate and reliable testing and analysis.
- Establish and implement QA laboratory policies procedures and effective methods to uphold highquality standards.
- Support regulatory inspections and audits addressing any observations or findings promptly.
- Maintain uptodate knowledge of regulatory changes and emerging trends in sterility assurance and quality assurance.
- Lead mentor and develop an impactful team of sterility assurance environmental monitoring and QA laboratory professionals.
- Develop a culture of continuous improvement collaboration and excellence within the team.
- Collaborate with other departments including Manufacturing Research & Development and Regulatory Affairs to ensure collaborative integration of sterility assurance environmental monitoring and QA laboratory activities.
- Participate in crossfunctional project teams and provide sterility assurance environmental monitoring and QA expertise to support product development and commercialization.
- Find opportunities to improve processes and implement initiatives that enhance sterility assurance environmental monitoring and QA laboratory efficiency and effectiveness.
- Stay updated on standard methodologies and technological advancements in sterility assurance environmental monitoring and quality assurance.
How Will You Get Here
Qualifications:
Education
Bachelors degree or equivalent experience in Microbiology Biology Chemistry or a related field. Advanced degree preferred.
Experience
10 years of experience in sterility assurance/environmental monitoring and quality assurance within the pharmaceutical biotechnology or medical device industry.
8 years of leadership experience with a track record of successfully leading and developing impactful teams.
Deep technical understanding of sterility assurance from a science and compliance perspective.
Current in technological and compliance developments across the manufacturing industry (e.g. filling technology Annex 1 interpretation)
Competencies
Strong analytical and problemsolving skills with the ability to make datadriven decisions.
Excellent communication and interpersonal skills with the ability to collaborate effectively across functions and levels of the organization.
Experience with regulatory inspections and audits.
Strong capability to influence personnel and management across the organization
In depth knowledge of pharmaceutical contract manufacturing Quality Assurance Compliance Quality Control and Regulatory Affairs.
Experienced in direct professional interactions with customers and internal business partners.
Ability to achieve results in a matrixed organization using representatives from different cultures and embracing diversity.
PHYSICAL REQUIREMENTS:
The position requires basic mobility skills to move around the office including standing walking stooping and kneeling. It also involves occasional lifting and carrying of light to medium weights. Good hand and finger dexterity is needed for typing as well as clear vision for using a computer and reading materials. Sitting reaching talking and hearing are also required for extended periods.
BENEFITS
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and
development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
Director
Employment Type
Full-Time
