AbbVie Area Commercial QA Head EEMEA in Zwolle, Netherlands
Area Commercial QA Head EEMEA
Netherlands, Overijssel, Zwolle
4 additional locations
PolandCzech RepublicNetherlands, OverijsselLithuania
As Area Commercial QA Head EEMEA you are responsible for providing quality assurance support for quality system requirements and QA activities associated with pharmaceutical products, medical devices, combination products and biologics.
This role provides strategic and tactical leadership across a regional area with multiple affiliate entities of varying operational and regulatory complexity to ensure business, quality and compliance objectives are met. Multiple QA teams across the region report direct or dotted line to the Commercial Area QA Head.
You will develop and support the strategic direction across the affiliate entities to ensure quality systems applicable to Affiliates within the region are implemented, monitored, maintained and improved upon. For this you will collaborate with partners at the affiliate, in global and area roles to ensure affiliate QA receives the required level of support needed to respond to AbbVie and/or external regulatory changes to maintain the required level of compliance.
This position can be based in the Netherlands, as well as Central Europe (Poland, Tsjech Republic or Lithuania e.g.).
Responsible for the integration and support of quality regulations: drug, biologics, device and/or combination products driving effective quality systems, procedures and/or processes within cross functional teams at the affiliate to ensure compliance as well as efficiency throughout our quality systems.
Responsible for management, leadership and oversight of multiple regional QA teams across multiple affiliate entities including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.
Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures. Integrate effective quality systems, procedures and/or processes within day to day operations across area of responsibility to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits and internal audits
Assess and manage quality events (e.g. potential quality defects) affecting affiliates within the region ensuring adequate escalation to regional/global stakeholders and coordination of communications to external regulatory authorities.
Evaluate and analyze metrics and quality indicators (lagging and leading) to oversee efforts to address underperformance or driving continuous improvement initiatives that will raise the bar.
Manage large scale critical Quality programs and projects affecting multiple affiliates within or across regions and requiring coordination with other local/regional/global stakeholders.
Coordinate support for preparation of internal audits and external regulatory inspections ensuring findings are adequately addressed and followed up on at local as well as regional levels.
What you should bring
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.
10+years in a quality or manufacturing role in pharmaceutical or device related industry.
Proven managerial leadership of technical professionals and/or leading global large organizations. Minimum 2 years supervisory/management experience. Budget management and finance acumen.
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations, Supply Chain.
Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.
Strong oral (with all levels of management) and written communication skills needed. Fluency in written and oral English is essential.
Excellent interpersonal skills a plus. Negotiation and influencing skills. Strong decision making skills.
Ability to manage across the enterprise.
Travel: Yes, 25 % of the Time
Job Type: Experienced