Work Schedule

Standard (Mon-Fri)

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 (DPD-NA) 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 high-quality standards.Support regulatory inspections and audits, addressing any observations or findings promptly.Maintain up-to-date 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 cross-functional 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

Bachelor’s 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 problem-solving skills, with the ability to make data-driven 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, forward-thinking organization, and outstanding career and

development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!