(Senior) Manager CQA

AbbVie

Ludwigshafen, Germany

Job Description:

The German Affiliate (Senior) Manager CQA Manager Germany (all genders) permanent and full-time is responsible for providing leadership and oversight of quality compliance matters at an operational and regulatory complex commercial entity in support of the quality system requirements associated with: pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business from receipt through shipment of final product are in compliance with Corporate, governmental, and local regulations. This position will have oversight of quality at the affiliate level as well as MAH responsibilities for centrally filed products.

Major Responsibilities:

Accountable for the integration and support of quality regulations at the affiliate: drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
Responsible for the management and oversight of a team 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.
Lead and oversee support activities related to product actions in the affiliate.
Assure key affiliate metrics are being monitored. Use data and facts to make decisions and to pursue compliance/continuous improvement opportunities. Conduct management reviews as per plan.
Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.
Host internal, external and MoH inspections & audits. Confidently knowing and understanding your affiliate business, licenses, distribution nodes, quality system applicability to support successful audits.
Accountable for supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.
Accountable for all activities governed by Good Storage and Distribution Practices at the affiliate, including monitoring of controlled temperature and cold chain shipments.
Represent affiliate QA or act as a lead in regional, global and cross functional teams, projects and programs, as appropriate.

Qualifications:

Master’s degree in chemistry, Pharmacy, Biology, other technical/scientific area.
5+ years experience in quality assurance, operations, regulatory or relevant experience preferred. 2+ years management experience preferred.
Full understanding of local GxP requirements.
General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations, how supplied, therapeutic uses/indications, strategic importance for the business and knowing how to get this information.
Ability to coach and develop others. Invests in people, amplifies strengths to build the best talent.
Makes decisions with minimal direction (within scope of role).
Excellence focused - Drives results by focusing on prioritization and continuous improvement.
Influencing - Understand your stakeholders and shape communication; can negotiate to win.
Leading with presence - Motivate their team, build relationships and inspire followership.
Business Acumen - Knowing how QA connects to the broader business objectives - We need to have an organization, culture and team members that will push the envelope - leaders that are embracing, promoting and driving change.
Excellent written and oral communication skills. Proficiency in English.
Familiar with TrackWise, ComplianceWire, OneVault.