ASSOC DIRECTOR - TS/MS STERILITY ASSURANCE 3196701

Full-Time Onsite with Paid Relocation

Our Award Winning Client, a nationally recognized leader in the pharmaceutical and biotech industry, is actively seeking a dynamic individual to join their team as the Associate Director TS/MS – Sterility Assurance. This is a full-time, onsite position with relocation assistance provided.

About Our Award Winning Client: Our client, a recipient of numerous industry awards, operates nationally and is dedicated to merging compassion with innovation in the pharmaceutical and biotech sector. They have established themselves as a global healthcare leader with a commitment to discovering groundbreaking medicines and enhancing disease understanding.

Position Overview: Associate Director TS/MS – Sterility Assurance

Joining our client's cutting-edge Parenteral, Device Assembly, and Packaging Facility in RTP, you will play a pivotal role in leading Sterility Assurance Technology and Sterility Assurance Validation teams. As the Associate Director, you will oversee contamination control strategy, aseptic process simulation, environmental monitoring, facility disinfection, gowning and hygiene, and sterility assurance risk management programs.

Key Responsibilities:

• Provide leadership to the team responsible for sterility assurance elements.
• Lead and mentor a technical staff, ensuring routine production support activities while managing technical projects and program oversight.
• Design and execute a technical and defendable contamination control strategy.
• Review and approve site GMP documentation, including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols, and summary reports.
• Collaborate with cross-functional teams to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Define and maintain inspection readiness activities; interact with regulatory agencies during inspections on cGMP, environmental monitoring, and sterility assurance issues.

Minimum Requirements:

• Bachelor's degree in engineering or a life science (Biology, Microbiology, etc.).
• Previous experience in a sterility assurance/contamination control role.
• Previous leadership experience.

Additional Preferences:

• Over 5 years of relevant experience in Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories.
• Experience with syringe technology and isolator filling technology.
• Experience in a start-up environment.

Qualities and Skills:

• Strong teamwork and interpersonal skills.
• Technical leadership, administrative, and organizational skills.
• Independent critical decision-making, complex problem-solving, and prioritization skills.
• Exceptional multitasking and communication skills.
• Ability to influence diverse groups.

Other Information:

• Overtime may be required.
• Availability off-shift to respond to operational issues as needed.
• Some travel required to other manufacturing sites and the corporate office.
• Applicant will work in various areas within the RTP site.
• Presence of allergens in the parenteral plant; mobility requirements and exposure to allergens should be considered when applying for this position.

US Citizenship or Green Card Holders only apply

Note: Resumes will be maintained in strict confidentiality until such time as we engage in a detailed discussion regarding a specific opportunity, and both parties mutually agree to proceed. We consistently receive new opportunities every day. Should your professional background closely align with the specific requirements of our client, we will promptly reach out to you to initiate further exploration of potential opportunities.

Job Type: Full-time

Pay: $116,589.09 - $193,687.93 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• What location of the USA or states are you interested in?
• 3196701 U.S. citizen or green card holder?
• Have you worked as Associate Director (TS/MS STERILITY ASSURANCE) recently?
• What type of compensation is desired for a new position?

Education:

• Bachelor's (Required)

Experience:

• Technical and defendable contamination control strategy: 5 years (Required)
• sterility assurance/contamination control: 3 years (Required)
• Aseptic Manufacturing: 5 years (Required)
• Quality Control: 5 years (Required)
• Quality Assurance: 5 years (Required)
• Microbiological Laboratories: 5 years (Required)
• syringe technology and isolator filling technology: 3 years (Required)

Ability to Commute:

• Durham, NC (Required)

Ability to Relocate:

• Durham, NC: Relocate before starting work (Required)

Work Location: In person