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15945en
- Contract
- English
- Mid-Senior level
- Research & Development
- Zug
- Healthcare & Life Sciences
Skills
Negotiation skills, Interpersonal skills, Verbal and written communication skills, Pharma industry, Biotech industry, GMP, EU/FDA regulations
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This vacancy has now expired
On behalf of our client, a leading global pharmaceutical company, we are now looking for a Senior Quality Release Lead.
Start Date: As soon as possible
Location: Zug
Workload: 100%
Duration: Until December 31st, 2024 (extension possible)
Your mission:
- Review and verification of batch release documentation according to local procedures and product specific checklist.
- Preparation and approval of the certificates of conformance and market-specific release documentation.
- Quality-relevant Status changes of the inventory in the Company’s systems.
- Influence the strategy of the manufacturing of our products at the CMOs and to sustain without disruption of the supply chain.
- Able to identify and drive improvements/updates of the GMP documentation related to Release activities and CMO oversight from release perspective.
- Identify and communicate timely to the management any supply risk or risk of batch rejection.
- Decisions with patient, global or regulatory impact must be taken in collaboration with upper management.
Your background:
- Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
- A minimum of 6 years of experience in similar position in pharmaceutical or biotechnology industries.
- Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling). Sound knowledge of cGMP requirements, EU/FDA regulations and
compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.
- Ability to develop effective working relationships with internal/external sites and cross-functional project teams.
- Negotiation skills.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
What’s Offered:
- Opportunity to work in a dynamic and innovative environment.
- Career development and growth opportunities within a global organization.
If you are interested in this opportunity and meet the qualifications outlined above, please apply here or email veronika.nakev@swisslinx.com with your updated resume.
Start Date: As soon as possible
Location: Zug
Workload: 100%
Duration: Until December 31st, 2024 (extension possible)
Your mission:
- Review and verification of batch release documentation according to local procedures and product specific checklist.
- Preparation and approval of the certificates of conformance and market-specific release documentation.
- Quality-relevant Status changes of the inventory in the Company’s systems.
- Influence the strategy of the manufacturing of our products at the CMOs and to sustain without disruption of the supply chain.
- Able to identify and drive improvements/updates of the GMP documentation related to Release activities and CMO oversight from release perspective.
- Identify and communicate timely to the management any supply risk or risk of batch rejection.
- Decisions with patient, global or regulatory impact must be taken in collaboration with upper management.
Your background:
- Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
- A minimum of 6 years of experience in similar position in pharmaceutical or biotechnology industries.
- Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling). Sound knowledge of cGMP requirements, EU/FDA regulations and
compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.
- Ability to develop effective working relationships with internal/external sites and cross-functional project teams.
- Negotiation skills.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
What’s Offered:
- Opportunity to work in a dynamic and innovative environment.
- Career development and growth opportunities within a global organization.
If you are interested in this opportunity and meet the qualifications outlined above, please apply here or email veronika.nakev@swisslinx.com with your updated resume.
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