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:

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

Job Description:

Johnson & Johnson is currently recruiting for a Director, Clinical Therapeutic Area Strategy ! in the R&D Quality (RDQ) Quality Assurance & Compliance (QA&C Organization. This position can be located in New Jersey, Pennsylvania or the European region.

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-00197

Beerse Belgium- Requisition #R-004014

High Wycombe, United Kingdom- Requisition #R-004016

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

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.

Key Responsibilities:

Auditing Strategy & Conduct

• Drives and delivers audit strategies/capabilities across Johnson & Johnson Innovative Medicine therapeutic areas (TA), ensuring implementation of risk-based methodologies and innovative tools, consistently across programs.

• Ensures appropriate allocation of Project Leads across TAs and relevant business responsibilities.

• Drives close partnerships 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 TA audit strategies continue to evolve in line with emerging needs and add value to the overall Quality and Compliance of JJIM clinical programs.

• Oversees the development and execution of tactical and operational audit plans to implement and deliver domain-specific audit strategies.

• Interfaces with Quality partners and business partners specifically supporting TA Clinical Programs to ensure audit strategies are effectively executed.

• Oversees therapeutic area management of R&D Quality QA audit activities, data, internal and external facilities and processes in GCP area to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. This includes for cause, complex and business critical audits.

• Provides regulatory and process expertise across all therapeutic areas.

• Conducts GCP audits & support GxXP Audits including resolution of CAPAs when applicable.

• Conducts peer review of audit reports when applicable.

Inspection Support

• Serve as the primary contact for Clinical QA related to HA Inspections, including inspection readiness and coordinating with other functions as needed.

• Acts on behalf of the Head of Clinical QA to provide oversight of domain-specific QA activities related to HA inspections, including inspection readiness and liaising with other functions as needed.

Training & Development

• Keep abreast of industry and company emerging regulations and trends and identifies relevant training and upskilling needs for Clinical QA.

• Oversees or develops training and development strategies for team to be able to support GCP compliance activities, and works within R&D Quality and with the business to deploy.

• Proactively and independently coaches and mentors others 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.

• Develops or is involved in the review and approval of training curriculum as applicable to area(s) of expertise.

• Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.

People Management

• Directly responsible and accountable for supervision and development of direct reports.

• Actively monitors direct reports skillsets and recommends actions to ensure the organization can support business objectives and maintain global alignment.

• Drives and implements talent strategies in a standard, fair and transparent approach to ensure audit skills remain current to support business objectives.

• Ensures a fair framework of recognition and reward, a mature sense of discipline, open communication and mutual respect.

• Fosters an environment which encourages the company’s Credo commitment to equal employment opportunity and the value of a diverse workforce.

Project Management

• Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company.

• Leverage data analytics tools to analyze relevant data sources. Evaluate and analyze the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.

Qualifications:

Education:

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

Required:

• Requires a 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, negotiation, and diplomatic skills.

• Advanced problem-solving skills.

• Advanced strategic thinking relative 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.

• Requires at least 12 years’ experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GXP GxP regulated discipline).

Other:

• This position may require up to 20% domestic & international travel.

• This position has an estimated annual salary of 142,000- 284,000USD$.

• 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)).

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

• 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

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 :

142,000- 284,000USD$.

Additional Description for Pay Transparency:

• This position has an estimated annual salary of 142,000- 284,000USD$. • 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)). • This position is eligible to participate in the Company’s long-term incentive program. - • 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