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

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•$102,000 - $177,100•Onsite

About The Position

Johnson & Johnson is seeking a Manager, External Quality, External Contract Laboratories (ECL) Americas, based in Horsham or Malvern, Pennsylvania, or Raritan, New Jersey. The role drives Quality Assurance, compliance, and technical support for external contract laboratories supporting Pharma R&D and Janssen Supply Chain, primarily in North America and Latin America. It contributes to divisional and companywide initiatives for managing external laboratories and works with internal quality, laboratory, procurement, product, and other stakeholder groups. The position is responsible for end-to-end quality and compliance oversight of external contract laboratories and supports the selection, development, and management of those laboratories. It helps implement continuous improvements to external laboratory management and supports consolidation and preferred-partner strategies, as well as onboarding and remediation for laboratories associated with acquisitions. The Manager leads laboratory qualification activities, including onsite and remote audits, and develops corrective action plans. The role may provide day-to-day quality oversight, manage deviations and corrective and preventive actions, support escalations, and ensure deviations are closed on time for release and stability. It also develops, negotiates, executes, and maintains quality agreements; proactively identifies and escalates risks; tracks and trends compliance metrics; and leads periodic business reviews with preferred laboratories. The role includes implementing the annual external-laboratory audit schedule and traveling to laboratory sites for audits and cGMP support. The position applies cGMP regulations and FDA and international requirements, provides timely reporting to stakeholders, and may require schedule flexibility on occasion. Up to 20% global travel is required. Candidates must already be authorized to work in the country of employment; immigration sponsorship and relocation support are unavailable.

Requirements

Bachelor’s degree or equivalent university degree; an Engineering, Science, or equivalent technical discipline is preferred.
At least 6 years of experience in a regulated pharmaceutical, medical device, or biotech environment, such as one regulated by the FDA.
At least 2 years of experience in pharmaceutical 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 external contract laboratories.
Knowledge of FDA and EMA regulatory requirements applicable to biologics and/or pharmaceutical 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 and oral communication skills.
Experience using pharmaceutical quality management 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 supporting Johnson & Johnson.
Proficiency in spoken, reading, and written English.
Authorization to work in the country of employment; immigration sponsorship is not available.
Ability to travel globally up to 20%.

Nice To Haves

Quality Assurance and Quality Control experience.
A degree focus in Engineering, Science, or an equivalent technical discipline.

Responsibilities

Drive Quality Assurance, compliance, and technical support for external contract laboratories supporting Pharma R&D and Janssen Supply Chain, primarily in North America and Latin America.
Participate in divisional and companywide cross-functional initiatives for managing external contract laboratories, collaborating with internal laboratory, quality, procurement, product, and other stakeholder groups.
Support the EQ-ECL function Leader in selecting, developing, and managing external contract laboratories globally.
Provide end-to-end quality and compliance oversight of external contract laboratories.
Support and implement continuous improvement of external contract laboratory management processes.
Support consolidation of external contract laboratories within DPDS and JSC-QC labs, including increased use of preferred partner networks.
Support onboarding of newly acquired external contract laboratories and associated quality and compliance remediation efforts.
Lead laboratory qualification activities, including onsite and remote audits, and develop corrective action plans to address deficiencies.
Provide quality oversight for day-to-day laboratory activities as needed, primarily managing deviations and corrective and preventive actions, and support escalations.
Manage systems to ensure deviations are closed on time for release and stability.
Independently resolve issues and collaborate with subject matter experts and other account owners to resolve issues.
Participate in Vaccines or other platform program quality and compliance initiatives at external laboratories as needed.
Apply cGMP regulations and FDA and international requirements to the role, and ensure timely and proper reporting to partners and stakeholders.
Develop, negotiate, execute, and maintain quality agreements with external contract laboratories.
Proactively identify laboratory risks, escalate critical-to-quality issues promptly, lead resolutions, and maintain an up-to-date risk register using compliance metrics and trends.
Lead periodic business review meetings with preferred external laboratories to review strategy, metrics, expectations, best practices, business matters, and integration with Janssen Quality Systems.
Implement the annual external contract laboratory audit schedule and obtain approval for site auditors to participate in the audit program.
Travel to external contract laboratory sites to conduct audits and provide cGMP assistance and quality oversight.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to policy and hire date.
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 a birth, adoption, or foster care placement.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a rolling 52-week period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.