Head of Sterility Assurance

vor 7 Monaten

Basel, Schweiz Takeda Pharmaceutical Vollzeit

**About the role**:
The Head of Sterility Assurance oversee all aspects of sterility assurance across Takeda Neuchâtel site including Monitoring Controls, Environmental Monitoring, and Utilities as well validation controls for facilities, equipment, and utilities. He/She leads the Sterility Assurance organization towards excellent and efficient processes and methods and inspires community to develop competencies and knowledge.

**How you will contribute**:

- Lead a team of sterility assurance professionals.
- Provide sterility assurance support for the qualification and validation of the manufacturing and warehouse areas, which includes Facility, Equipment, Environmental Monitoring program, Process Validation and Continued Process Verification (process monitoring).
- Provide a strategic direction about Sterility Assurance topic and develop tactical and strategic plans for continuous improvement short and midterm.
- Define EM strategy of the site.
- Lead sophisticated investigations into issues impacting Sterility Assurance (i.e. Adverse EM trends, media fill failures).
- Review & approve any Major/Critical deviations and change proposals with Sterility Assurance impact for the Neuchâtel site areas.
- Assist in the development, documentation, and management of the site contamination control strategy.
- Oversee the management of Microbiological investigations into any non-conformance in link with microbial testing (Out of Specification, Out of Action (OOA) or Out of Trend (OOT)).
- Prepare for, and support, internal and external audits (e.g. SwissMedic, FDA, corporate, customer).
- Actively lead and support projects, quality initiatives and continuous improvement programmes within the sterility assurance department.
- Participate, as required, in global project teams relating to Sterility Assurance and wider quality activities.
- Ensure that consistent standards for sterility assurance practices are applied across the Neuchâtel site.
- Keep himself up to date with new regulations, trends and best industry practices in relation to sterility assurance and provide trainings on that matter to a wide audience.
- Represent site in the Global Sterility Assurance Working Group, and facilitate harmonizing practices across sites in the Takeda network.

**What you bring to Takeda**:

- Minimum of a Master degree in Microbiology or a relevant scientific discipline (Biology, Microbiology, etc).
- At least 8 years of experience in the Pharmaceutical/Biotech industry, ideally in a matrix structure
- Highly experienced Professional Leader with significant Sterility Assurance leadership experience, Quality operations, and manufacturing background.
- Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
- Excellent communication skills (written and oral).
- An understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Organisation Skills: Ability to manage multiple priorities and know when to escalate issues for resolution.
- An understanding of GMP, ICH, USP and global compendia regulations and guidance's.
- Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, 5S etc).
- Ability to translate the vision and goals of the company and site to the teams.
- Enterprise mindset to ensure the right prioritisation for the site.
- Strong project management skills to support project delivery and operational readiness.
- Partners closely with and influences and coaches Quality operations, Operations on critical decision making and issue management on the sterility assurance aspects.
- Strong and close partnering and collaboration with stakeholders such as Manufacturing, Engineering, QA.
- A proven ability to lead cross functional teams and deliver on tight timelines.
- Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problem solving.
- Identifying and communicating risks in area of responsibility and across the site.
- Ability to challenge the status quo with a continuous improvement mindset.
- Provides leadership and guidance to the team and key customer.

**What Takeda offers you**:

- Competitive salaries.
- Full accident coverage.
- Participation in health insurance premiums.
- Advantageous pension plans.
- Subsidised meals.
- Financial participation in employee sports activities.
- Transport: support for local public transport passes, free parking, car sharing programme.
- Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies.
- Takeda Neuchâtel is an employer committed to its employees and to future generations.

**Learn more about Takeda Neuchâtel**:

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