Senior Manager CQA Manager Germany all genders permanent and full-time

The German Affiliate (Senior) Manager CQA Manager Germany (all genders) permanent and fulltime 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 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.

Details to (Senior) Manager CQA Manager Germany (all genders) permanent and fulltime: 

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 :

Qualifications:

• Masters 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.

What is in for you:

• a varied field of activity that requires your flexibility and curiosity about challenges
• an open corporate culture
• attractive remuneration
• flexible working time models for a healthy worklife balance
• corporate health management with comprehensive health and sports programs
• company social benefits
• Diverse career options in an internationally active company

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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 status as a protected veteran or any other legally protected group status.

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Work :

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