Leader of the BCR (Biological Critical Reagent) - Netherlands
Want to know company name or location? Company managed [?]
- Quality Operations at our company Biotech (around 100 people) has the following five sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents (BCRs).
- The Quality Department must ensure adequate quality systems are in place to support the manufacturing, packaging, testing, storage, and distribution of products according to our manufacturing division’s Policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.
- The BCR Hub (around 20 employees) is responsible for supporting Biological Critical Reagent programs within the Biologics franchises and for managing the complete life cycle of reference materials, control samples and other materials used in support of release and stability testing of biological products.
- Next to that the BCR Hub is responsible for:
- Supporting transfer of BCRs of new Biological products from our Manufacturing Division Commercialization / our Research Laboratories to the BCR Hub;
- Supporting complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability) of BCRs within the global Biologics franchises;
- Supporting distribution (in time delivery) of BCRs to company laboratories, contract laboratories and regulatory agencies.
- Reporting into the Executive Director Quality Operations the BCR Hub Lead must lead the hub to successfully supply compliant BCRs in a competitive way. The BCR hub is undergoing a transformational change and in parallel the hub must also meet growing supply demands. The change is based on five elements, i.e.:
- Execution and measuring success;
- GMP compliance improvement;
- Training people and building best teams;
- Vendor management.
Desired skills & Experience:
- Master’s/ PhD degree in biological/ pharmaceutical sciences, biochemistry or biochemical engineering;
- At least 10 years of relevant experience in Quality Operations in a pharmaceutical or biotechnological environment;
- Proven track record in planning, executing and measuring success, GMP compliance improvement and vendor management;
- Broad analytical knowledge in the field of BCR analysis;
- Strong GMP and MPS Lean knowledge and thinking;
- Strong process thinking skills, business process improvement skills (also strong in coaching how to optimize business processes) and a production mentality:
- Thorough understanding of end- to-end supply chain/ S&OP processes, planning processes and customer demands;
- Strong analytical and technical skills;
- Well-developed coaching & people development skills;
- Strong leader with mature and exemplary interpersonal skills;
- Strong communication skills on operational/ local, tactical as well as strategic/ senior management level;
- Excellent oral and written communication skills in English and a strong preference (or willing to learn) for Dutch.
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
A good place to work
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.