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 Med Tech, 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:

People Leader

All Job Posting Locations:

Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for Director, Clinical Audit Strategy within in the JJIM R&D Quality organization! This position can be located in the US (Titusville, NJ or Springhouse, PA), Belgium (Beerse), United Kingdom (High Wycombe), or Switzerland (Allschwil).

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): North America- Requisition #R-060968
EMEA– Requisition# R-062279

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Position Summary:

The Director, QA Clinical Audit Strategy will be a key member of the R&D Quality (RDQ) Clinical QA leadership. This role will lead a global team of Clinical QA Program Leads and drive cross-functional partnerships in a highly matrixed organization. Main responsibilities will include, but are not limited to:

• Drives and delivers audit strategies/capabilities across all GCP audit types (including Clinical Investigator Site Audits, Clinical Program Audits, System Audits, ESP Audits, and LOC Audits), ensuring implementation of risk-based methodologies and innovative tools, consistently across programs.
• Drives close partnership between Clinical QA audit strategy and execution teams to foster collaboration, ensure seamless E2E clinical audit process and strong connectivity of all Clinical QA audit data to enhance the overall value of Clinical QA.
• Drives cross-domain and cross-functional partnerships to ensure Clinical QA audit strategies continue to evolve in line with emerging needs and add value to the overall Quality and Compliance of JJIM clinical programs.
• Interfaces with Quality partners and business partners specifically supporting TA Clinical Programs to ensure audit strategies are properly developed and effectively executed.
• Conducts GCP audits & support GxP Audits including resolution of CAPAs when applicable.
• Serve as the primary contact for Clinical QA related to HA Inspections, including inspection readiness and coordinating with other functions as needed.
• Leads and develops a team of direct reports; C coaches and mentors other Clinical QA team members to support talent development and training, foster effective leadership skills and competencies to shape a collaborative and efficient auditor organization that meets current and future business needs.
• Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company.

Qualifications:

Education:

A minimum of a Bachelor of Science (BSc) degree is required with a focus in science, life science or pharmaceutical science is required. An advanced degree (M.D, Ph.D, MSc or Pharm D) would be desirable.

Required:

• Deep knowledge and understanding of the drug development process, GxP functional compliance regulations (national and international), sound research and development practices, scientific terminology, company quality assurance procedures and policies, and quality evaluation techniques.
• Excellent communication, organization, investigation, and negotiation skills, and be diplomatic
• Advanced problem-solving skills.
• Advanced strategic thinking related to new and emerging technologies and analytics, and ability to identify opportunities where creative capabilities may be applied within QA audit processes.
• Track record of leading global strategic initiatives in the R&D Quality and Compliance areas.
• Experience of leading and advancing a global team of direct reports.
• A minimum of 12 years relevant work experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP regulated discipline).
• This position may require up to 20% domestic & international 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, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$150,000.00 - $258,750.00

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)).

This position is eligible to participate in the Company’s long-term incentive program.

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