For our location in Ludwigshafen, Germany we are looking for a
Director Quality Assurance (all genders)
We are looking for a Director Quality Assurance who wants to contribute to improving the quality of life of millions of patients around the world and make a remarkable impact on people's lives.
The Director Quality Assurance is responsible to ensure site compliance to cGMP of all markets where products manufactured by the site are commercialized and to ensure compliance to AbbVie requirements, by building, monitoring and maintaining a sustainable site quality system.
Look forward to the following responsibilities
- be responsible for Change Management; Quality Risk Management; Manufacturing QA; Sampling; PQR; Cleaning Validation; Batch Record Review
- ensure Quality Oversight for all qualification and validation projects within LU Operations
- be responsible for investigation, assessment and approval of non-conformities and deviations according to AbbVie policies/SOPs and German drug act
- be responsible for assessments, investigation of customer complaints and approval of reports
- be responsible for department and execution of strategic measures/projects
- represent the responsible area during inspections and audits
- be responsible for compliance with local, AbbVie and third-party quality, regulatory, safety and environmental rules, policies and regulations
- lead and direct the QA Operations department, ensuring your employees’ development and effective succession planning by actively supporting Performance Excellence Programs
- direct costs, establish priorities for decisions with high financial impact and work to improve bottom line growth as well as to achieve agreed budget targets while guaranteeing Quality Oversight for all quality systems within QA
We look forward to hearing from you, if you have proven track record with
- Quality Management System
Building, monitoring and improving quality systems, complying with GMP regulations/corporate policies requirements and expectations. Keeping updated on industry trends and regulatory bodies expectations / guidelines / regulations evolution, anticipating Quality System changes required to comply in a sustainable way, based on deep operations understanding.
- Quality Management System Performance
Ensuring quality system performance in terms of compliance is appropriately monitored, through internal audits, metrics and trends evaluation and appropriate decision are taken by Site Heads (QA and Operations Site Director) on changes, improvements and resources through management review process.
- Audits & Inspection Management
Relationship with authorities and global functions – Managing relationships/contacts with authorities to maintain site authorization. Leading inspection readiness activities representing the site in global compliance initiatives, bringing added value from site in definition of global Quality System.
...and, in particular, if you have experience with:
- Site Training Management System
Maintaining site training system and ensuring it is appropriate and effective.
- Supplier Quality Management
Maintaining supplier qualification system, ensuring suppliers are timely qualified and appropriate agreements are in place, ensuring their performance is monitored and control processes for products services and materials are set accordingly.
- 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.
- Regulatory Compliance / Stability Management
Management of the stability program for products from Operations LU. Ensuring compliance with regulatory filings. Management of the Compendial Compliance process. Implementation of regulator notifications from AbbVie Regulatory or external customers to ensure compliance with filings. Answering of deficiency questions from regulatory bodies.
- Degree in Chemistry / Pharmaceutical Chemistry / Pharmacy. Certification to be a Qualified Person according to German Drug Act §14, 15, 19 and EU directive 2003/94/EG is preferred
- minimum 10 years experience in Pharmaceutical industry, possibly on Drug Product (alternatively API, DP and packaging would be of advantage)
- at least 5 years demonstrated experience in Operations Quality Assurance
- good understanding of operations business (from supply to final product delivery)
- excellent knowledge of GMP regulation (EU/FDA) and agencies expectations
- active participation to GMP working groups and direct management in inspection are preferred
- strong leadership skills and significant experience as line manager, leading large teams
- passion for performance and drive for innovation
- high degree of self-motivation/proactivity and efficient results-oriented way of working
- excellent communication and presentations skills
We are looking forward to your application. Please provide information about your salary expectations and possible start date.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.