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Irfa******
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Germany
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Last Update: 23.03.2019 at 12:00
Job Type
Full Time
Start
ASAP
Duration
8 Month +
Place
Munich, DE
Country
Germany
Category
Sales and Marketing
Description
Key Responsibilities
- Primary decision maker for QA GMP oversight of BD&L arrangements and transfers and key point of contact for cross regional deals (Global)
- Responsible for proactive policy setting and Quality evaluation - this includes development, implementation and continuous improvement of globally standardized data, processes, procedures and standards
- Facilitate the global Quality decision making process for Global, Regional and Local BD&L arrangements in the high level reviews at the partner selection board and the in depth evaluation for the supply point committee (SPC)
- Establish and maintain Liaison with key stakeholders Global BD&L (and Country management), Regional/Local QA, LRC, MS&T, SPC. Engagement with Sandoz and Pharma Development on supplier selection
- Ensure that potential compliance gaps and risks in relation to BD&L arrangements are identified and flagged early and continuous improvement is implemented
- Work closely with Sandoz stakeholders to ensure development of robust processes in order that key ESO launches are not jeopardised due to poor quality oversight or lack of proactive Quality management. Timely input to the Sandoz Global Launch Review board on a monthly basis
- Competitive salary
- Performance based annual bonus
- Work/life integration
- Eligible to Sandoz pension plan
- 30 working days' holiday per calendar year
- Subsidised on-site cafeteria
- Free shuttle bus between Sandoz and Holzkirchen train station
- Additional benefits
- Degree or PhD in Life Sciences, Pharmacy or Medicines
- At least 10 years’ experience in the pharmaceutical industry, including operative experience in QA and/or Production/Technical Operations, with at least 5 years in Quality (Assurance) and involvement in regulated activities
- Extensive GxP experience (based on different roles in Quality Assurance)
- Broad understanding of global expectations of health authorities in GxP regulated areas
- 5 or more years of demonstrated leadership and accomplishments in an international matrix organization i.e. successfully leading an organization or project of high impact
- English fluent in speaking and writing, second language desirable
Seniority Level
Mid-Senior level
Industry
- Pharmaceuticals
Employment Type
Full-time
Job Functions
- Quality Assurance
- Manufacturing