Director of External Quality, Localization
vor 9 Stunden
The **Director, External Quality - Small Molecules - Localization** leads the quality oversight of external manufacturers specifically intended to optimize market access and commercial opportunities, ensuring patient access to our innovative product portfolio.
The role is responsible for establishing and managing commercial quality operations of multiple Small Molecule products manufactured and/or packaged in External Manufacturers located in Russia, Saudi Arabia, Morocco, Algeria, Turkey, Egypt, among others.
The director leads the quality aspects of these alliances/External Manufacturers (EMs) to ensure that products are available to meet customer needs, provide the highest quality and achieve maximum relationship value through accelerated innovation, supplier integration, process improvement, and collaboration. The position is involved in early engagement in selection process and assessing EM capabilities.
This position will provide Quality Assurance, Compliance and Technical Support for External Manufacturers (EMs) as applicable. Providing leadership in the selection, development and management of External Manufacturers under its scope. Providing QA support for technology transfer and improvement of existing manufacturing processes.
Partner with EM in defining Quality Strategy and Supplier Development Plan through internal benchmarking and knowledge sharing. Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence (e.g., PEx, Lean etc.).
This position will be responsible for developing functional strategic plan and ensuring alignment to Global EQ and JSC strategic plans. Lead work team to deliver business and quality goals with agility and patient focus, fostering innovative thinking and balanced management of quality/compliance risks with business needs. Work closely with Business Partners: Partnerships & External Supply (PES), Business Quality (BQ), Local Operating Countries (LOCs), etc. and other supply chain and enterprise functions to identify new opportunities, efficiencies or solve problems to meet business needs.
**Main Tasks/Responsibilities**
- Direct all of the Quality and Compliance activities related to External Manufacturing (EM) in the assigned work team and provide the proper interface to business partners (PES, Quality Assurance functions, technical owners and other stakeholders).
- Escalate issues as appropriate to Senior Management and support the Executive Management Reviews.
- Act as senior level interface to key Health Authorities for External Manufacturers
- Interface with the Product Management and Customer Management teams to supply the markets.
- Assess current quality systems and recommend improvements to enhance quality and reduce cycle time
- Monitor trends, identify risk, recommend and implement appropriate mitigation actions.
- Provide cGMP compliance support to External Manufacturers by investigating and resolving quality issues.
- Ensure effective and compliant execution of quality system processes including nonconformance, CAPAs and change controls
**Other duties**
- Investigate customer product quality complaints and adverse trend
- Provide Quality oversight on technical transfer teams
- Manage Health Authority Inspections of EM, monitor EM response and implementation
- Travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight
- Act as delegate for Sr Director EQ in quality and compliance related matters, in case of absence and when requested
**Qualifications**
- Minimum Bachelor's Degree, preferably Advanced degree (MS, MBA) in Chemical, Scientific or Technical discipline is required
- A minimum of 10 years experience in Pharmaceutical, Medical Device, Biotech
**Required knowledge, skills and abilities**:
- Experience in drugs, biologics or medical devices quality assurance and/or manufacturing is required.
- Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers is required.
- In depth knowledge of global cGMP requirements is required.
- Seasoned people leader (direct reports) is required.
- Project management experience is required.
- Strong team collaboration mentoring and coaching skills are required; experience in leading cross-functional, multi-site and/or international teams.
- Proven track record of successful business or process improvements required.
- Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style required.
- Demonstrated strategic thinking capabilities, ability to define a vision for the future. Ability to translate vision to strategy, and strategy to execution.
- Demonstrated ability to build and nurture strong, positive relationships with business leadership and partners in Global Quality, Procurement, manufacturing, DPDS and across the enterprise. Strong negotiation skills. Ability to build relationships and confidence with suppliers w
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