Head of Quality Assurance (m/w/d
Location
Cuxhaven | Germany
Job description
Head of Quality Assurance (m/w/d page is loaded
Head of Quality Assurance (m/w/d
Apply locations DE - Cuxhaven time type Full time posted on Posted 30+ Days Ago job requisition id R0017067
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The position Head of Quality Assurance (m/f/d) is to be filled on an temporary basis as a sick leave replacement ( maximum until November 2025).
The Head of Quality Assurance, working with all members of the leadership team and reporting to the Site Head of Quality, will lead the planning and managing of long-term site quality goals for the QA department. Quality assurance responsibilities include managing and providing strategic guidance to approximately 15 employees in accordance with regulatory guidelines and Elanco quality standards. The role partners closely with other site departments and the global QA network team.
Key objectives/deliverables:
- Management of the quality assurance department, budget, and personnel planning
- Coaching and develop direct reports incl. succession pipeline within the department
- Ensure GMP-Compliance and adherence to regulatory requirements in the manufacture, testing and release of the products
- Monitoring, regular evaluation and adjustment of the quality systems and processes
- Management of the batch release process (GMP-compliant and regulatory release)
- Provision of non-routine and routine support Quality in the process teams
- Ensure support in the preparation and management of change controls, deviations and the conduct of investigations, assessment and triage of non-conformances that arise
- Ensuring the creation, monitoring and management of overall process instructions as well as relevant work instructions
- Communication with national and international authorities in the context of inspections (preparation/implementation/follow-up) or other enquiries
- Ensuring monitoring of contract manufacturers/testing laboratories
- Ensuring quality agreements with third parties and vendors incl. approvement
- Ensuring the implementation of internal inspections
- Management interfaces Supply Chain Management Aqua and Poultry as well as Regulatory Affairs
- Presentation of quality data in the Control Tower and SQLT
- Implementation and monthly feedback of quality KPIs
- Approval of documents according to SOP specifications
- Site and community engagement
- Promote and foster a culture of continuous improvement within all processes within QA
- Develop and drive a QA productivity agenda
- Driving the culture of safety first, quality always
Minimum requirements:
- MSc in Chemistry, Pharmacy, Biology, Microbiology or comparable. PhD is desirable
- A minimum of 10 years of professional experience and technical expertise in aseptic pharmaceutical industry, in Quality Control or Quality Assurance
- Minimum 5 years of experience as a team leader or manager
- Proven track record of managing budget and employment development
- Strong expertise with the global quality standards (EU GMP)
- Prioritization skills
- Written and oral communication skills (German and English)
- Critical decision-making skills
- Strong problem solving skills
- Strong interpersonal skills, ability to work in a cross-functional team
- Must be self-motivated
What we can offer:
- Attractive remuneration incl. variable pay
- 40 hours / week
- 30 days vacation
- Freedom to use your own initiative
- Interesting and varied working environment in a modern and growing global company in the pharmaceutical industry with exciting development opportunities
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at .
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