Head of SOPs and Compliance (m/f)

Job description

Description

Would you like to utilize your expert knowledge in biopharmaceutical compliance procedures and your strong knowledge in regulatory requirements?
If so, seize this opportunity and join us as Head of SOPs and Compliance within our department Biophamaceutical Quality!

Duties & Responsibilities

·  You are the technical and disciplinary leader of the team ‘SOPs and Compliance'
·  You manage and oversee quality assurance processes (e.g. Change Control, Deviations, CAPA, education programs, method validation, etc.) as process owner within the departments Quality Control and Analytical Development (with regard to e.g. establishment and improvement of the required processes, coaching and training of teams etc.)
·  Within Quality Control and Analytical Development you act as consultant for all kind of cGMP and Compliance issues
·  You also act as interface to Quality Assurance and other compliance functions within global BP
·  Furthermore you manage quality improvement projects around interfaces to other compliance functions in global Biopharmaceuticals, corporate quality and production and represent the departments Quality Control and Analytical Development in these projects
·  You manage and oversee the workflow for the administration of project specific SOPs and other product specific GxP documents (e.g. validation protocols, validation reports etc.)
·  The support and management of customer audits and inspections of GxP and non-GxP agencies (e.g. FDA, EMA, TÜV, BfArM etc.), BI compliance functions and consultants belong to your further tasks
·  You investigate and resolve observations noted during inspections/audits and collaborate to an adequate responding to audits/inspections
·  Additionally you manage and establish KPIs, reporting and scorecards for the field of responsibility

Requirements

·  You hold a diploma, master's or doctoral degree in Pharmaceutics, Chemistry, Biotechnology, other related fields or comparable education with relevant longtime experience
·  You have at least 3 years pharmaceutical experience in operational functions within the pharmaceutical industry and profound knowledge of quality assurance, analytical testing and/or manufacturing
·  Knowledge of biotechnological manufacturing, analytical testing and respective guidelines are desired
·  Your in depth knowledge of compliance procedures and pertinent international regulations (EMA, FDA, WHO, ICH, etc.) is essential for this position
·  Experience as an auditor and in managing inspections (as escort) is of advantage
·  Furthermore you are experienced in applying risk management tools and risk-based decision making
·  Your excellent communication and negotiation skills in German and English enable you to communicate efficiently and effectively with your colleagues and partners
·  In addition you are characterized by your strong leadership skills and the ability to manage complex, cross-functional projects and programs

Our Culture

Boehringer Ingelheim is a research-driven pharmaceutical company and one of the top 20 pharmaceutical firms worldwide. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally in over 100 countries and has more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 23.1% of its net sales.

Contact

For further information please contact Recruiting Services.
Stefanie Seidel, Phone: +49 (0) 7351 54-187794