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J&J Innovative Medicine is recruiting for a Manager External Quality - External Contract Labs reporting to the Director Eternal Quality.
Objectives And Responsibilities
* Drive Quality Assurance, Compliance, and Technical Support for External Quality Contract Laboratories (ECLs) within Pharma R&D and Janssen Supply Chain, mainly in EMEA and APAC regions.
* Serve in teams or major cross-functional projects at divisional and companywide levels managing external contract labs globally, collaborating with sector leads, internal and external stakeholders.
* Support the selection, development, and management of External Contract Labs worldwide.
* Oversee quality and compliance of external contract laboratories.
* Implement strategies for continuous improvement of external contract lab management processes.
* Support the consolidation plan of external contract labs, including increased use of Preferred Partner networks.
Main Duties and Responsibilities
* Support onboarding of new ECLs during acquisitions and related remediation efforts, working with EQ, PQM, DPDS, and JSC-QC/QA teams.
* Lead qualification activities through audits, develop corrective action plans.
* Oversee day-to-day activities like deviation and CPA management, support escalations.
* Manage systems to ensure deviations are closed timely.
* Solve issues independently and with stakeholders from analytical development or EQ account owners.
* Participate in Q&C initiatives at ECLs, especially for vaccines or other platforms.
* Apply cGMP, FDA, and international regulations.
* Report timely to partners and stakeholders.
* Occasional flexibility in work schedule for cGMP support and oversight.
* Develop, negotiate, and maintain Quality Agreements with external labs.
* Identify and escalate risks, monitor compliance via metrics, and maintain Risk Register.
* Conduct periodic Business Review meetings with external labs to review strategies and share best practices. Implement and oversee external lab audit schedules, including site visits for audits and quality oversight.
Minimum Qualifications
* Bachelor’s degree in engineering, science, or related technical discipline.
* At least 6 years in pharmaceutical, medical device, or biotech regulated environments.
* Minimum 2 years in Pharma Quality Control or Analytical Development labs.
* Extensive QA, QC, and compliance experience.
* Knowledge of FDA/EMA regulatory requirements for biologics/pharmaceutical testing.
* Ability to manage projects independently and meet timelines.
* Experience working with global cross-functional teams.
* Strong communication skills.
* Experience with Pharmaceutical QMS systems and auditing.
* Ability to build relationships with leadership and suppliers, strong negotiation skills.
* Proficiency in English (speaking, reading, writing).
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