Do you have a deep understanding of Sterile Manufacturing and Aseptic best practices?
Are you looking for an opportunity to have Quality Assurance (QA) oversight of an Aseptic Processing Program?
Are you located in Houston, Texas, or are you willing to relocate?
Fraser Dove International is working exclusively with an established biotechnology organisation specialising in pioneering cell therapies and new medicines. Operating worldwide, they are dedicated to becoming the world’s leading pharma healthcare organisation.
Our client is seeking a QA expert to have QA oversight of the Aseptic Processing Program and review policies and procedures appropriately.
Discover more about our Sterility Assurance Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Sterility Assurance Manager, you will be measured against the following objectives:
1) Producing a strategic plan for the development and implementation of the Sterility Assurance & Aseptic Processing Programmes across the site.
2) Developing the microbial control strategy and leading Sterility Assurance Board.
3) Working closely with multiple stakeholders to implement sterile assurance activities.
What you will do:
As the Sterility Assurance Manager, your duties and responsibilities will include:
- Providing oversight and sterility assurance expertise to Operations to assure aseptic processing meets the US and international requirements.
- Assuring facility and quality systems’ state of compliance with internal requirements and appropriate regulations.
- Participating in the development of action plans to correct deficiencies and improve quality processes.
- Providing microbiological expertise to support EENs, deviations, CAPAs and complaints related to aseptic processing.
- Supporting regulatory and client audits as Aseptic Sterility Assurance subject matter expert.
- Providing microbiological and sterility expertise for cGMP documents including SOPs, batch records, validators and specifications.
- Managing and leading a team of 1-2 specialists.
- Providing guidance, oversight and support for Operations and QA/QC specialists.
What you will bring:
These are the skills and experience you will need to succeed as the Sterility Assurance Manager:
- The ability to work autonomously with little guidance from senior management.
- A passion for teaching people the what and why, by conveying the sterility assurance programme.
- Persistence and determination to overcome setbacks and drive business performance.
- Ability to implement sterility assurance activities within the manufacturing process by working with stakeholders to affirm why they need to be implemented.
- Advanced experience managing a QA team.
- Deep understanding of Sterile Manufacturing/Fill/Finish and Aseptic best practices.
- Bachelor’s degree in a life sciences related discipline.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Relocation assistance
- Medical/dental insurance
Got what it takes?
To apply for the Sterility Assurance Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Katy Barber – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.