Director, Clinical Audit Strategy

Johnson & Johnson Innovative Medicine • Hopewell Township, NJ

3d

About The Position

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.

Requirements

• A minimum of a Bachelor of Science (BSc) degree is required with a focus in science, life science or pharmaceutical science is 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.

Nice To Haves

• An advanced degree (M.D, Ph.D, MSc or Pharm D) would be desirable.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director