- Develop a strategy and roadmap for quality oversight (Annual Quality Plan) aligned with business and site objectives
- Set quality goals, objectives, and KPIs for factories in collaboration with Corporate Quality, leading a high-performing Global Quality System team
- Support site quality teams during regulatory inspections, customer inquiries, visits, and audits
- Provide regulatory oversight of government regulations (including cGMP, GDP, ISO, dietary supplements, etc.)
- Aid in formulating and tracking CAPA plans post-inspections and audits
- Offer technical and regulatory guidance, mentorship, and talent development
- Utilize regulatory, industry, and technical knowledge to address global quality system challenges
- Foster consensus on key quality matters to ensure compliance and optimize best practices
- Establish and maintain a global quality management system through electronic platforms (eQMS, eDMS, eLMS), ensuring regulatory compliance and tool qualification per CVS and global data integrity regulations
- Manage the creation and revision of global documentation (quality policies, global SOPs, and guidelines) that support the quality management processes
- +15 years of professional experience in quality functions within the pharmaceutical, biotech, or medical device industry in a senior management role
- Advanced degree in Pharmacy, Chemistry, Biology or related Science
- Strong knowledge of managing and implementing quality systems
- Team player, analytical, and able to conceptualize and manage in a fast-paced environment
- Able to work in the complexity of matrix organizations
- Strong leadership and communication skills to manage international teams
- Strong knowledge of MS Office suite and IS tools
- Willingness to undertake travel up to 40-50%
- Fluency in English (min. C1) – any additional language is advantageous
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Vice President Quality System Excellence - Frankfurt, Deutschland - Pacific International Executive Search
Beschreibung
Pacific International, a globally recognized retained executive search firm, is dedicated to empowering Fortune 500, FTSE 100, and high-growth enterprises in building exceptional C-suite, senior-level, and strategic leadership teams. Our adaptability, agility, and forward-thinking ethos distinguish us in the ever-evolving business landscape.
Pacific has been exclusively retained to assist our client, an innovative market leader within the pharmaceutical industry with employees, aiming to improve the health and well-being of millions of patients. They manufacture and deliver lifesaving products with the ultimate objective of improving people ́s life conditions. Their high standards of quality and innovative technologies have allowed them to transform the European market and become leaders in the field.
We are seeking a strategic, analytical, problem-solver, dynamic, and experienced Vice President to join their team. The ideal candidate will have a proven track record in the quality function of pharmaceutical, biotech, or medical device companies in a senior management role. You will bring extensive experience implementing successful quality systems and ensuring their excellent performance and safety, as well as harmonizing protocols, ensuring optimal safety standards globally, and strengthening the organization of safety frameworks across the business.
Key Responsibilities:
Qualifications:
For further information on this position and a confidential discussion about your career please contact:
Duván Tovar
Office
At Pacific International, diversity, equity, and inclusion are at the core of who we are and what we do. Our commitment to these values is unwavering and we proudly champion diversity on behalf of our clients in every Executive Search mandate we undertake. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. In pursuit of these objectives, we actively encourage applications from individuals of all backgrounds and identities.
Nutzer der Berufsbezeichnung Vice President Quality System Excellence in Frankfurt am Main
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Olena Bozhenko
Accountant / Project manager