Quality Assurance Lead/ Associate Director- Biotech Job

Date: Jan 23, 2019

Location: Oss, NB, NL

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Requisition ID: QUA008102


For our Biotech organization in Oss we are currently hiring a:





Quality Assurance Lead/ Associate Director- Biotech


The organization
Quality Operations (around 125 people) at MSD Biotechnology Operations Oss must ensure adequate quality systems and controls are in place to support the manufacture, testing, storage, and distribution of biotech drug substances according to corporate policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring. The department is build up of 3 main groups, i.e. Q IPT (supporting operational processes/batch release), Quality control (testing of incoming materials, intermediates, drug substance release & stability) and Compliance (support the business with effective Quality systems and ensuring adherence to those systems).





For more information about MSD Biotech, please watch the MSD Biotech Oss video below.
https://www.youtube.com/watch?v=yzzdXlQNzYY




The Position
Reporting into the Compliance Director Biotech, the Quality Assurance Lead is responsible to manage and provide an independent Quality oversight over all GMP related activities across the site in meeting our Manufacturing Division priorities Compliance, Supply, Strategy and Profit Plan. The leadership style is one of collaboration, challenging, 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.





Job Responsibilities
• People Management/coaching of a group of about 10-15 employees;
• Ensuring GMP compliance for Biotech Operations and Quality Control by approving a.o. the following topics:
o Equipment, utilities and facilities qualification& change control and related deviation/CAPA approval
o APR/PQR generation
o Reviewing and approval of GMP procedures and associated documents;
o Environmental monitoing
o Validation Master Plan including monitoring according planning
• Monitoring, initiating  and ensuring  administration and implementation of data (e.g. performance indicators) and ensuring governance of the strengths and weaknesses of the various units in Oss Biotech to drive improvement
• Accountable for the systems to guarantee all are managed/ closed in a timely manner.
• Manage the execution of the operational process and visual management, clarify operational status to others in CoE and IPT and ensure problem solving – to achieve the team targets in a culture of Continuous Improvement by deploying MSD Six Sigma tools within the QA group.
• Monitor the status of GMP action steps and other relevant performance indicators. Create an integral and deep insight in the quality status of Biotech
• Governance of the GMP compliance project portfolio and link to site strategy (Hoshin Kanri) of improvement initiatives on IPT/CoE level;
• Participating in above site initiatives.
Qualifications


• 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);
• Thorough knowledge and experience in interpreting current regulatory requirements (e.g. FDA, EU, Canada, Japan, Brazil, China) 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 and Dutch . 





About MSD 
MSD 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.





MSD. Inventing for life. For more information, visit our website: www.werkenbijmsd.nl





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.





Information

For more information about the position, please contact Joost van Zutven, Executive Director Quality Operations Biotech Oss, by phone: +31(0) 6 20491473.





Application
If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.
 


Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Biotech, Manager, Law, CAPA, Lean Six Sigma, Science, Management, Legal

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