Director External Quality Lm Emea
4 weken geleden
Essential Job
**Responsibilities**:
General Objectives
The function provides QA oversight for multiple External Manufacturers in the EMEA region.
Act as a coach and mentor for (Sr.) Managers, contractors, consultants, and Associates.
The position provides leadership to a team of Quality Assurance professionals supporting strategic manufacturing projects in the EMEA region.
Contribute to the overall development, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical products.
The position requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.
Demonstrated ability to take ownership for and lead the resolution of complex Quality and Compliance issues.
Position requires travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight.
Specific Objectives
- Provide Quality Assurance, compliance and technical oversight to a portfolio of large molecule Drug Product and Drug Substance manufacturers in the EMEA region.
- Drive a culture of continuous improvement across a group of external manufacturers. Develop, monitor and effectively utilize dashboards, control charts and quality indicators and take action to correct those situations which are not in line with established controls or targets. Lead the development of corrective action plans and monitor implementation.
- Ensure that all relevant QA related concerns at the external manufacturing sites are
- raised to Janssen management. Ensure that the manufacturing operations for Janssen at the external manufacturer site run smoothly from a QA point of view and in a compliant manner.
- Provide leadership to a team of Senior EQ Account Managers for the management of strategic projects and key accounts.
- Ensure that personnel are recruited and trained to support activities in line with business needs
- Build and continue to develop a strong, solid, cohesive team within EQ LM EMEA.
- Continue to develop a High Performing Credo based Culture with direct reports and across wider EQ team in which every associate is valued and recognized for their contribution to our success.
- Provide strategic quality direction to colleagues in PES and MSAT, more specifically, in view of the business development projects, NPI and site transfers.
- As a member of the EQ team that directly reports to the Large Molecule Platform Quality Head, provide strategic leadership to the wider EQ LM team.
- Partner with PES, MSAT, and Planning in the framework of the Quartet in order to assure continued market supply in a lean and effective manner.
- Partner with key supporting functions including PQM, Compliance, regulatory, internal Site QA, to ensure all activities within external manufacturing are carried out in compliance with corporate, cGMP and other regulatory requirements.
- In partnership with Product Quality Management execute the defined responsibilities of Product Quality Owner, where applicable.
- Provide Quality oversight and participate on technology transfer teams.
- Provide quality and compliance oversight for new product introductions at external manufacturing sites
- Drive the development, writing and implementation of quality procedures
- Support JJRC inspections at the EM.
**Qualifications**:
- Master’s degree in pharmacy, pharmaceutical sciences, biology or chemistry
- Work experience: 12+ years relevant industry experience
- Extensive (> 5 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production).
- Advanced degrees are a plus and may reduce the experience required. Demonstrates knowledge of Quality Assurance, Quality Control and Compliance.
- Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development is required
- Experience in management of a team
- Experience in the development, implementation and review of SOPs for interactions with contract manufacturers is preferred.
- Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues is required.
- Basic Principles of Aseptic Processing is preferred.
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
- Ability to quickly process complex information and make critical decisions with limited information
- Proficient in written and spoken English
- Excellent computer proficiency e.g. MS Office, SAP
Other requirements
- Able to connect easily, team worker, able to manage across cultures
- Amount of travel 10-25% (international travel included in EMEA, occasionally to the US)
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will recei
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