Attention: This position is based in Oss, The Netherlands. The candidate selected will be given international relocation.
For our Biotech organization in Oss we are currently hiring a:
Quality Systems Lead/ Associate Director- Biotech
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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.
Quality Operations Biotech (around 60 people) is responsible for ensuring that our Manufacturing Division Oss manufactures, tests and releases Biological Drug Substances and Bulk Drug Products in accordance to applicable local and international regulations. To this end the various Quality departments actively collaborate and set standards for all other Integrated Process Teams (IPTs) and CoEs of our Manufacturing Division Oss as well as regularly interact with other Manufacturing Division sites.
The individual selected will report into the Quality Director Biotech, the Quality Systems Lead is responsible to manage and provide an independent Quality oversight over all GMP related activities across the site and in meeting our Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan. The leadership style is one of collaboration, coaching and facilitating the CoE team and personnel outside the group on GMP requirements to drive a high performance organisation. This will require a substantial amount of his/ her time within the area engaging and communicating with the CoE team members and influencing and creating/ supporting/ promoting GMP Compliance across the entire site.
- People Management of a group of about 10-15 employees;
- Ensuring GMP compliance for Biotech Operations by managing the following topics:
o Owner of Quality Management (Sub) System;
o Execution of site Quality Plan;
o Ensure cGMP training topics are developed and are enrolled throughout the organization.
- Assurance of effective Internal audit program;
- Coordination & hosting of Health Authority Inspections and Customer Audits, monitoring follow-up of audits;
- Qualification and auditing external laboratories as required;
- Reviewing and approval of GMP procedures and associated documents;
- Expert role in Global Quality network;
- Advising the CoE's/ IPT's and ensure implementation of quality related knowledge, procedures and guidelines;
- Assuring compliance versus Licenses, GMP certificates, SMF. Provides the necessary documentation for submissions and renewals;
- Acting as Significant Investigation Lead;
- Monitoring, initiating and ensuring administration and implementation of data (e.g. performance indicators) and documentation (e.g. SOP´s);
- Driving a culture of Continuous Improvement by deploying Merck Six Sigma tools within the CoE Group on projects such as: Problem Solving, reducing cycle time, Lean principles within the process;
- Governance of the GMP compliance project portfolio and link to site strategy (Hoshin Kanri) of improvement initiatives on IPT/CoE level.
- Master's or Bachelor's Degree or similar level by working experience (e.g. Biology, Biotechnology or Bioprocessing);
- At least ten years of experience in relevant and managerial experience (of which at least 3 years in a Quality department);
- Proven good track record with regulatory inspections and customer audits;
- Thorough knowledge and experience in interpreting current regulatory requirements (e.g. FDA, EU, Canada, Japan, Brazil) as they apply to a biologics manufacturing operation;
- Proven compliance mindset and experience with implementing Quality Systems;
- Broad knowledge of manufacturing and/ or analysis processes;
- Demonstrated excellent interpersonal skills with the ability to influence, motivate, and lead teams.
- Able to carry out and implement a quality mindset within the Biotech Site;
- Strong project management skills & proven ability to manage complex projects;
- Knowledge of and experience in applying Lean Six Sigma and Lean methodologies;
- Excellent oral and written communication skills in English (Dutch is a plus).
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.
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