Our client is a leading global pharmaceutical leader in innovation. The Director, Sterility Assurance Global Labs is responsible for ensuring that the companies Laboratory programs are aligned with the overall Sterility Assurance Engineering programs and company strategy. This is a Global role operating from Ireland in the long-term and will work closely with the Senior Director of Global Sterility Assurance Engineering.
The successful candidate will serve as the global technical leader for Global Laboratories in the areas of sterilization, aseptic processing and microbiology with responsibility for all company sites.
Significant aseptic processing experience within pharmaceuticals Labs is required.
Responsibilities of Director, Sterility Assurance Global Labs:
- Participate in defining company policy and developing company strategies with respect to Laboratory cleanliness, sterilization, clean rooms, pure water systems and related areas.
- Work with the Senior Director of Global Sterility Assurance Engineering to establish long-range sterilization strategies within the Laboratories for all the company products.
- Have managerial responsibility for the company Sterility Assurance functions within the Labs. This individual will need to actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.
- Support new product development from Labs perspective, collaborating with Product Development and suppliers to provide design inputs as well as to validate sterile and microbiologically controlled products.
- Work with Supply Chain to establish, validate and maintain clean Laboratory environments, processes and utilities.
- Responsible for Global Labs compliance to applicable Quality Regulations, ISO and AAMI standards, and other regional standards.
- Provide input in the design of Laboratory processes, controlled environments and packaging from a microbiological standpoint.
- Provide input for the design of water systems and controlled environments and cleanliness control strategies.
- Interact with external regulators and various levels of company management, working across many functional areas.
- A high-level knowledge of standards including AAMI and ISO.
- Excellent oral and written skills and ability to communicate both up and down the business ladder within franchise or technical competency area.
- A demonstrated ability to work in a collaborative, team oriented environment.
- Independent organizational and time management skills.
Technical Responsibilities of Sterility Assurance Global Labs:
- Aseptic processing experience within pharmaceuticals Labs.
- Sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes).
- Microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, BET).
- Environmental control and monitoring.
- Reusable device reprocessing and water systems validation.
- Sterility Assurance support to new product development and launch from Laboratory perspective.
- Compliance to applicable regulations and standards in the subject areas of Sterility Assurance for laboratories.
- Inspection and submission support and health based risk assessment.
Requirements for Director, Sterility Assurance Global Labs:
- Bachelor’s Degree with Microbiology, Biology, Engineering or related discipline is required. Advanced Degree (MS or PhD) is preferred.
- 12+ years of experience in pharmaceutical or combination products industry with a GMP and/or ISO regulated environment.
- 8+ years of direct people management experience.
- Proficient computer software such as Excel, Word and PowerPoint, and analytical software.
- Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a pharmaceutical facility.
- A demonstrated competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
- Understanding of the sterilization process, microbiological lethality as it relates to both product design and sterilization processing.
- Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience is desired.
- Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.
- Experience in interacting with Regulatory Authorities.
- Experience with conducting technical assessments of in-house and contract sterilization processes or contract microbiological laboratories is preferred.
- A proven track record on trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via robust CAPA.
NOTE: The new appointee will initially work closely alongside colleagues for 2 year period at the companies US plant, before transitioning to the company facility in Ireland.
For further details, please contact Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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