Director External Quality, Advanced Therapies

Johnson & Johnson; Horsham; On-site; USD 146,000 - 252,000; Full time

Job summary

A leading healthcare company is seeking a Director of External Quality-Advanced Therapies located in Horsham, PA, Raritan, NJ or Baltimore, MD. The role encompasses oversight of quality assurance, compliance, and management for cutting-edge drug product manufacturing in cell therapies. Ideal candidates will bring extensive experience in pharmaceutical quality and demonstrate strong leadership capabilities across multiple sites.

Benefits

Medical, dental, and vision insurance

401(k) retirement plan

Paid vacation and sick leave

Long-term incentive program

Qualifications

• Minimum of 10 years in Pharmaceutical or Biotech in regulated environments.
• Experience in quality assurance in sterile processes.
• Leadership experience in cross-functional teams.

Responsibilities

• Oversee quality systems for drug product readiness.
• Direct all QA and compliance activities for BiCAR.
• Act as the main contact for external manufacturers.

Skills

Team collaboration

Strategic Thinking

Problem-solving

Leadership

Interpersonal skills

Education

Bachelor's or equivalent University degree

Advanced Degree (MS, MBA)

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Baltimore, Maryland, United States, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Director, External Quality-Advanced Therapies! This position can be located in Horsham, PA, Raritan, NJ or Maryland.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Position Summary:

This position provides Quality Assurance, Quality Control, Compliance and Quality Management oversight for the tech transfer process, clinical and commercial readiness for the BiCAR CMO, based in North America. The role will report to the EQ Advanced Therapies Sr. Director.

This role provides strategic direction, leadership and coordination of the different quality functions interacting with the CMO: ECSQ, EQ, JJRC, PQI, ATQ. The role will represent quality in site readiness meetings and will ensure alignment to the CMC/VMT councils. This role acts as Single Point of Contact for all Quality matters towards the CMO with the intention to ensure that all Quality related matters are ready for commercial manufacturing readiness as per program milestones. The incumbent is accountable to escalate issues to Quality Sr leaders as appropriate.

This position provides leadership and management to a group of professionals that have the quality oversight of supply chain activities and execution of quality systems in support of drug product manufacturing for cell therapy clinical and commercial products.

The position holder works closely with other Quality functions, Technical Support, IT and Operations at the CMO. He/she will ensure an aligned quality oversight of tech transfer, inspection readiness and supply chain activities, in support of the clinical and commercial readiness of the CMO.

Key Responsibilities:

• Directs all the Quality and Compliance activities related to BiCAR drug product manufacturing site, to assure flawless qualification, tech transfer and compliant supply for commercial batches.
• Ensures implementation and execution of quality systems in support of the J&J BiCAR product. Assesses current quality systems and recommends improvements in order to enhance quality, to promote continuous improvement and to promote pro-active quality culture.
• Is the first point of contact for CMO site leadership and for J&J business and technical partners (G&P, MSAT, R&D)
• Is part of the tech transfer team, tracks and highlights/escalates challenges and quality risks in the execution and makes sure the implementation is aligned with the committed design and timelines.
• Escalates issues as appropriate to Senior Management and supports the Executive Management Reviews.
• Assists external manufacturers with regulatory inspections and provides follow-up on regulatory commitments
• Ensure the plans for system implementation at the CMO, ERP/MES, LIMS and other Quality related systems are adequate and GMP compliant
• Provides regular progress update to Senior Management / Steering Committees as applicable

Qualifications

Education:

A minimum of a Bachelors or equivalent University degree is required, Advanced Degree (MS, MBA with a focus in a Pharmaceutical, Chemical, Scientific or Technical discipline preferred.

Experience and Skills:

Required:

• A minimum of 10 years of experience in Pharmaceutical or Biotech or highly regulated environment
• Experience in quality assurance or manufacturing in sterile processes and facilities
• Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers
• In depth knowledge of global cGMP requirements, including laboratory
• Seasoned leader with direct people and organizational leadership experience
• Strong team collaboration, mentoring and coaching skills
• Experience in leading cross-functional, multi-site and/or international teams.
• Interpersonal skills to build and nurture long term relationships, influence and negotiate acceptable outcomes, in multiple disciplinary, cross-cultural environments in External Manufacturers and J&J.

• Refined skills in the following Global Leadership areas required: Integrity and Credo-based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Collaboration and Teaming; Sense of Urgency; Prudent Risk-taking; Self-awareness and Adaptability; Diversity and Cross-cultural inclusion experience; Results and Performance Driven.
• Experience in External Manufacturing, CMO start-up and Quality System Development.
• The incumbent has to work at the CMO site on a routine basis (approx. 40%) – with a target to be weekly on site

Preferred:

• Experience in cell therapy manufacturing
• Advanced knowledge and proven application of Process excellence tools is preferred.
• Based in NJ/PA/MD area

Other:
- This position may require up to 40% domestic travel.
- This position has an estimated annual salary of $146,000-$251,850 USD$
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Employees are eligible for the following time off benefits:
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
This position is eligible to participate in the Company’s long-term incentive program.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

The anticipated base pay range for this position is :

$146,000-$251,850 USD$

Additional Description for Pay Transparency:

- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Employees are eligible for the following time off benefits: - Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year This position is eligible to participate in the Company’s long-term incentive program.