Manager, External Quality

Title: Manager, External Quality

Location:

• Holly Springs, NC.

Hybrid

Full time

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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, North Carolina (Any City), Raleigh, North Carolina, United States

We are searching for the best talent for a Manager, External Quality to be based in Holly Springs, NC.

Purpose: In this position you will be responsible for providing quality leadership and oversight of external manufacturers in the North America region, ensuring consistent delivery of pharmaceutical drug substance that meets or exceeds safety, regulatory compliance, and product standards. The position works closely with External Manufacturing, Quality and Compliance functions, Internal J&J sites, Product Quality Management, and Global Manufacturing Science and Technology.

You will be responsible for:

• Ensuring effective and compliant execution of quality systems at external manufacturing (EM) sites.
• Building relationships with internal and external partners with emphasis on Operational Excellence, Trust & Transparency, Agility & Resiliency, Partnership, and Innovation.
• Preparing EMs for successful health authority inspections; identifying regulatory compliance risks, and following up on associated commitments.
• Providing oversight for technology transfer and new product introduction activities; leading PAI readiness and support associated health authority filings and approvals.
• Participating in the onboarding, qualification, and ongoing monitoring of external partners.
• Partnering with manufacturing sites and quality counterparts to identify and resolve quality issues and complaints, including development of robust CAPA plans and effectiveness checks.
• Reviewing and approving product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.
• Contributing to process mapping of key quality systems to identify and implement innovative ways of working.
• Monitoring quality performance through tracking of key performance indicators.
• Partnering with key internal stakeholders in support of supply chain to meet patient supply requirements.
• Assessing current quality systems and recommending improvements to improve compliance and optimize processes.

Qualifications/Requirements:

• A minimum of a Bachelor's or equivalent University Degree is required with a focus in engineering, science, or an equivalent technical discipline preferred.
• A minimum of 8 years working in QA and/or QC functions in pharmaceutical industry.
• Experience in biotherapeutic manufacturing.
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
• Experience with manufacturing-facing support of clinical or commercial manufacturing operations.
• Ability to work independently in support of a portfolio of products and suppliers.
• Ability to quickly process complex information and make critical decisions with limited information.
• Strong interpersonal, communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization.
• Experience with cell culture, biotherapeutic drug substance manufacturing preferred.
• Experience working with external manufacturers preferred.
• Experience developing or reviewing electronic batch records preferred.
• Experience in development or application of digitally-integrated quality metrics preferred.
• This full time role is located in Holly Springs, North Carolina.
• The position is remote-hybrid with an expectation of 3 days in-office at the manufacturing site in Holly Springs, North Carolina and up to 2 days remote work per week.
• May require up to 10% domestic travel.

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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Business Alignment, Coaching, Collaborating, 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