Manager, External Quality, External Contract Laboratories (ECL) Americas

Johnson & Johnson Innovative Medicine • Horsham, PA

5d • $102,000 - $177,100 • Hybrid

About The Position

Drives Quality Assurance, Compliance and Technical Support for External Quality contract laboratories (ECLs) within the Pharma R&D organization and Janssen Supply Chain, primarily in North America and Latin America regions. This position serves in teams or major cross-functional project initiatives at the Divisional and the J&J companywide level with regard to management of the external contract labs used globally. Closely works together with other J&J sectors leads for external contract labs, Internal JSC-QC Lab representatives, DPDS, Site Quality leads, Product Quality management, Global Quality Lab Systems, Global Procurement and other stakeholders. Supports the EQ-ECL function Leader in the selection, development and management of External Contract Labs globally. Responsible for the end-to-end Quality and Compliance oversight of external contract laboratories (ECLs). Supports and implements the strategy for continuous improvement of the external contract lab management processes. Supports the Pharma consolidation plan of external contract labs within DPDS and JSC-QC labs including increased usage of Preferred Partner networks. Active role in the support of new company acquisitions’ onboarding of new ECLs, and associated Q&C remediation efforts, where the Manager will work closely with the various EQ, PQM, DPDS and JSC-QC/QA groups towards effective and timely qualification, and resolution of issues that may surface. Lead qualification activities of ECLs, by performing on-site and remote audits, develop corrective action plans to remediate deficiencies. May be involved in quality oversight for day-to-day ECL activities, primarily deviation and CPA management (e.g. Vaccines). Will support escalations, as required. Manage all utilized systems to ensure deviations are closed in time for release and stability. Independently solve issues as well as solving issues with key stakeholders like Subject matter experts from Analytical development or other EQ Account owners. May partake in the Vaccines or other platform programs’ Q&C initiatives at the ECLs. Apply cGMP regulations, FDA and international requirements to all aspects of the position. Ensure timely and proper reporting to partners and stakeholders. Position may require flexibility in working schedule on occasion, in order to provide cGMP assistance and quality oversight. Responsible for development, negotiations, execution and maintenance of Quality Agreements with the different External Contract Laboratories. Pro-actively identify risks at the external contract labs, escalate critical to quality issues in a timely manner and lead resolutions. Monitors compliance of external contract labs through tracking and trending metrics resulting in up-to-date Risk Register. Drive periodical Business Review meetings with preferred external contract labs in order to review strategy; metrics; expectations; share best practices; business acumen; further integration with Janssen Quality Systems. Implement the yearly external contract lab audit schedule and receive approval of site auditors to participate within the audit program. Travel to External Contract Lab sites to conduct audits, provide cGMP assistance and quality oversight.

Requirements

• A minimum of a Bachelor’s or equivalent University degree is required; a focus in Engineering, Science or an equivalent technical discipline preferred
• A minimum of 6 years of experience in Pharmaceutical, Medical Device or Biotech regulated environment (e.g. FDA)
• A minimum of 2 years of experience in Pharma Quality Control or Analytical Development laboratories or closely related experience
• Extensive experience in Quality Assurance, Quality Control and/or Compliance.
• Ability to develop Quality Systems and provide cGMP compliance support to ECLs
• Knowledge of FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals’ testing
• Ability to independently manage work to meet project objectives and timelines
• Ability to work within multiple cross functional teams with global composition
• Strong interpersonal and written/oral communication skills
• Experience in using Pharmaceutical QMS systems
• Auditing experience
• Ability to build and nurture strong, positive relationships with business leadership and partners in Global Quality, Procurement, DPDS and across the enterprise.
• Strong negotiation skills.
• Ability to build relationships and confidence with suppliers who support J&J.
• Proficiency in spoken, reading and written English is required.
• Candidates must already have authorization to work in the country of employment.

Nice To Haves

• Quality Assurance and Quality Control experience

Responsibilities

• Drives Quality Assurance, Compliance and Technical Support for External Quality contract laboratories (ECLs) within the Pharma R&D organization and Janssen Supply Chain, primarily in North America and Latin America regions.
• Supports the EQ-ECL function Leader in the selection, development and management of External Contract Labs globally.
• Responsible for the end-to-end Quality and Compliance oversight of external contract laboratories (ECLs).
• Supports and implements the strategy for continuous improvement of the external contract lab management processes.
• Supports the Pharma consolidation plan of external contract labs within DPDS and JSC-QC labs including increased usage of Preferred Partner networks.
• Active role in the support of new company acquisitions’ onboarding of new ECLs, and associated Q&C remediation efforts.
• Lead qualification activities of ECLs, by performing on-site and remote audits, develop corrective action plans to remediate deficiencies.
• May be involved in quality oversight for day-to-day ECL activities, primarily deviation and CPA management (e.g. Vaccines).
• Manage all utilized systems to ensure deviations are closed in time for release and stability.
• Independently solve issues as well as solving issues with key stakeholders like Subject matter experts from Analytical development or other EQ Account owners.
• May partake in the Vaccines or other platform programs’ Q&C initiatives at the ECLs.
• Apply cGMP regulations, FDA and international requirements to all aspects of the position.
• Ensure timely and proper reporting to partners and stakeholders.
• Responsible for development, negotiations, execution and maintenance of Quality Agreements with the different External Contract Laboratories.
• Pro-actively identify risks at the external contract labs, escalate critical to quality issues in a timely manner and lead resolutions.
• Monitors compliance of external contract labs through tracking and trending metrics resulting in up-to-date Risk Register.
• Drive periodical Business Review meetings with preferred external contract labs in order to review strategy; metrics; expectations; share best practices; business acumen; further integration with Janssen Quality Systems.
• Implement the yearly external contract lab audit schedule and receive approval of site auditors to participate within the audit program.
• Travel to External Contract Lab sites to conduct audits, provide cGMP assistance and quality oversight.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager