Head of Quality Assurance Compliance
vor 7 Monaten
"Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.- Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.-
**Head of Quality Assurance Compliance & Improvement (f/m/d)**
- Bad Vilbel | Germany (DE) | Full-time | Permanent**What you can expect**
- You ensure that the site's quality management system is efficient and complies with company standards and local and global regulations
- You are responsible for reviewing QMS at the site, identifying gaps, developing mitigation plans and ensuring their implementation
- You are in charge of the efficient implementation of change control, the CAPA system, training and documentation management and the timely closure of PQRs and customer complaints.
- You ensure that site and products (medicinal products, food supplements, medical devices and cosmetics) comply with all relevant regulations (GxP, ISO, HACCP) applicable to each category of product manufactured
- You inform the site management team and the cluster quality officer in a timely manner about important quality-related or regulatory issues and risks that may impact product quality or compliance
- You work with internal business partners on mitigation plans, ensures adequate resourcing and execution of the plans
- You proactively prepare for and manages Health Authority inspections and customer audits by ensuring the site is “inspection ready” at all times
- You prepare appropriate and timely responses to all inspection observations, identify appropriate and thorough corrective and preventive actions and ensure that CAPAs are implemented in a timely manner
- You ensure that a robust training system, which includes initial and ongoing GMP and SOP training, is in place and its delivery is monitored across the site
- Together with the site manager and the site leadership team, you promote a strong quality culture and behaviour at the site
- You drive process improvements through the use of recognised quality tools, internal audit programmes, appropriate CAPA systems and feedback systems (complaints, etc.).
- You participate in global projects and ensure timely implementation at the site
**Who we are looking for**
- You have a University degree in pharmaceutical sciences, natural sciences or related field
- You have at least 5 years of experience in the pharmaceutical industry as well as leadership experience
- You have proven track record in quality assurance and compliance
- You have a high sense of quality and responsibility, combined with a lot of initiative as well as organisational and negotiating skills
- You have strong leadership and communication skills and are able to lead a highly qualified, committed and motivated team
- You have fluent German and English skills
**What we offer**
- An open corporate culture with fast decision-making processes and a lot of potential for your personal development
- Individual development and training opportunities
- Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
- Job ticket for the RMV region and Job Bike
- Childcare allowance
- Health-promoting offers such as Wellpass or the STADA Gym (free of charge)
- Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund
- And much more...- Would you like to find out more about our STADA values? Find out in just 2 minutes with our value game- STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.
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