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

6046-JANSSEN SUPPLY GROUP, LLC. Legal Entity; Horsham (PA); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, External Quality for External Contract Laboratories (ECL) in the Americas, located in Horsham, PA, Malvern, PA, or Raritan, NJ. The role drives QA, compliance and technical support for ECLs across NA and LATAM, leading audits and QA programs with global partners.

The candidate will develop QMS, quality agreements, and remediation plans, coordinating with DPDS, JSC-QC, PQM, and Global Quality to ensure timely issue resolution and continual improvement.

Qualifications

• Bachelor’s degree or equivalent in a technical discipline is required.
• At least 6 years in pharma/biotech or related regulated environments is required.
• At least 2 years in Pharma Quality Control or Analytical Development laboratories is required.
• Experience in QA, QC and/or Compliance is required.
• Ability to develop Quality Systems and provide cGMP compliance support to ECLs.
• Knowledge of FDA/EMA requirements for biologics/pharmaceutical testing.
• Strong cross-functional collaboration skills and project management.

Responsibilities

• Lead qualification activities of ECLs, including on-site and remote audits.
• Develop corrective action plans to remediate deficiencies.
• Provide quality oversight for day-to-day ECL activities and deviations.
• Manage QA documentation, cGMP compliance, and escalation of quality issues.
• Coordinate audits, approvals, and maintenance of Quality Agreements with external labs.

Skills

Quality Assurance

Quality Control

Auditing

Regulatory Compliance

GMP

SOP

QMS

Regulatory Environment

Education

Bachelor’s degree or equivalent

Tools

Pharmaceutical QMS systems

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description: We are searching for the best talent for a Manager, External Quality, External Contract Laboratories (ECL) Americas located in either Horsham, PA, Malvern, PA or Raritan, NJ.

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Purpose: 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, escalation 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.

Qualifications / 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.

Preferred:

• Quality Assurance and Quality Control experience

Other:

• Proficiency in spoken, reading and written English is required.

Required Skills:

• Business Alignment
• Coaching
• Collaboration
• Compliance Management
• Continuous Improvement
• Fact-Based Decision Making
• Good Manufacturing Practices (GMP)
• ISO 9001
• Process Improvements
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Regulatory Environment
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Technical Credibility

Preferred Skills:

• Business Alignment
• Coaching
• Collaboration
• Compliance Management
• Continuous Improvement
• Fact-Based Decision Making
• Good Manufacturing Practices (GMP)
• ISO 9001
• Process Improvements
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Regulatory Environment
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Technical Credibility

The anticipated base pay range for this position is : $102,000.00 - $177,100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.