What are the responsibilities and job description for the Manager, Sterility Assurance position at Orano Med, LLC?
Job description
Ideal qualifications
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Orano Med is seeking a Manager, Sterility Assurance.
The Manager, Sterility Assurance will be responsible for developing, implementing, and maintaining contamination control strategies. Ensuring compliance with global regulatory standards and managing sterility assurance initiatives across the site. The ideal candidate will be a strong leader with proven experience in building and guiding high-performing teams, collaborating with cross-functional groups, and driving a culture of compliance and continuous improvement.
Key Responsibilities
- Provide overall leadership and direction for sterility assurance and contamination control programs within a radiopharmaceutical GMP manufacturing environment.
- Develop and implement long-term sterility assurance strategies, aligned with regulatory expectations and business objectives.
- Serve as the site subject matter expert (SME) in sterility assurance, aseptic processing, and environmental monitoring.
- Represent sterility assurance during internal and external audits, including with regulatory bodies (e.g., FDA, EMA) and customers.
- Collaborate with executive leadership to establish clear sterility assurance metrics, continuous improvement initiatives, and site-level risk reduction strategies.
- Oversee the design, implementation, and execution of robust contamination control programs (cleanroom qualification, media fills, aseptic techniques, gowning qualification, cleaning/disinfection programs, etc.).
- Lead and approve sterility assurance risk assessments, deviation investigations, and root cause analyses for aseptic and microbiology-related events.
- Ensure corrective and preventive actions (CAPA) are effectively implemented and tracked to completion.
- Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams to align sterility assurance practices with site quality objectives.
- Act as the sterility assurance lead during regulatory inspections, audits, and customer visits, ensuring the site is always in a state of inspection readiness.
- Manage, coach, and develop the sterility assurance team to build technical expertise and leadership capabilities.
- Provide aseptic training and mentorship for manufacturing and quality staff to reinforce contamination control practices.
- Foster a culture of compliance, accountability, and continuous improvement across the site.
Our Full-Time Benefits
- Competitive compensation
- Health, Dental, and Vision insurance - with generous employer contributions
- 401(k) with employer matching and contribution amounts
- Life insurance and Short- and Long-Term Disability insurance provided by the company
- Generous Paid Time Off and holiday schedules
- Numerous Training and Development opportunities
- and more...
Ideal qualifications
Qualifications Required
Education
- Bachelor's degree in microbiology, Biology, Molecular Cellular Biology or related field.
- Minimum of seven (7) years of experience within the pharmaceutical or biotechnology industry.
Experience
- Minimum of 5 years in a leadership role
- The industry experience should be focused on microbiology laboratory experience relating to environmental monitoring, microbiology laboratory operations, sterility assurance or related roles supporting current Good Manufacturing Practices (cGMP).
- Strong knowledge and experience with FDA regulations, United States Pharmacopeia (USP) guidance chapters and International Organization for Standardization (ISO) standards.
- Strong understanding of microbiological testing methods and quality control procedures.
- Excellent attention to detail, communication, organizational, and collaboration skills.
Please Note: The provided salary information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.
Salary range annually: $120,000 - $140,000
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Salary : $120,000 - $140,000
