AbbVie Head of Product QA (f/m) in Ludwigshafen, Germany
Head of Product QA (f/m)
Germany, Rhinland-Palatinate, Ludwigshafen at https://abbvie.referrals.selectminds.com/jobs/1074/other-jobs-matching/location-only
Quality Assurance at http://abbvie.referrals.selectminds.com/landingpages/quality-assurance-opportunities-at-abbvie-105
Apply for Job
Share this Job
Join our Talent Community
The Head of QA Compliance/Product QA is responsible to ensure that all products are manufactured and tested in compliance requirements of the marketing authorisation and with Good Manufacturing Practices
The Head of QA Compliance / Product QA represent the site in place of the QA Director and the site Director in all relationship with regulatory authorities, both local and from markets all over the world, liaising for the site in GMP matters and ensuring site manufacturing authorisation/licence is maintained and renewed.
Batch Record review and batch release - Ensuring product manufacturing and testing process is reviewed, all exceptions which may result in product non conformities or quality issues and all changes having quality or regulatory impact are appropriately evaluated/managed to enable batch release. Ensure batch release is executed in compliance with regulation and in a timely manner to satisfy business needs.
QP Duties - Ensure all QP duties are fulfilled according to Annex 16 EU GMP regulation requirements by managing a team of QP.
Product and processes performances – Ensuring product and processes performances are appropriately monitored through, track and treding process, trends evaluation, product quality review, stability review and appropriate decisions are taken by Site Heads (QA and Site Director) or by global CMC teams on changes and/or improvements needed.
Regulatory Compliance/NPI - Leading New Product Introduction. Ensuring compliance to filing and compendial requirements.
Relationship with authorities and global AbbVie functions. Managing relationship/contacts with authorities in relationship to product quality and to maintain site authorization. Representing the site in place of QA Director and Site Director. Representing the site in global compliance initiatives, bringing added value from site in definition of global Quality System.
People Management – Leading a department of over 10/15 people to deliver major responsibilities of the function, ensuring performance reviews, talent management, development and training.
Compliance processes efficiency – Ensuring compliance processes are continuously measured and improved and resources usage is optimized, through application of business excellence and innovation concepts, supporting Site financial needs on overhead control. Anticipating constrains and remediation.
Ensuring departmental compliance to all relevant Quality/H.R./EHS&E policies, procedures and guideline
Degree in Chemistry / Pharmaceutical Chemistry /Pharmacy and Certification to be a Qualified Person
Minimum 10 years of experience in Pharmaceutical industry, possibly on Drug Product (API as alternative may be acceptable, both API and DP would be strong plus).
Demonstrated experience in operations, Quality Assurance (at least 5 years), NPI/pharmaceutical develoment
Excellent knowledge of GMP regulation (EU/FDA), agencies expectations. Active participation to GMP working groups is preferred. Direct management of inspection is preferred
Good understanding of operations business (from supply to final product delivery)
Strong leadership skills and significant experience as line manager
Articulating what is wrong, why, and how to resolve it across the cross-functional team
Passion for Performance and drive for innovation
High degree of self-motivation/proactivity and efficient results-oriented way of working
Excellent communication and presentation skills
We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Learn more about AbbVie Deutschland at www.abbvie.de . Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.