Director of Continuum of Care at KCRHA overseeing various projects and federal funding administration. Collaborating across divisions and ensuring high - quality applications for funding.
About the role
- Director leading Clinical Audit Strategy for Johnson & Johnson's R&D Quality division, managing a global team and cross-functional partnerships to enhance audit processes. Ensuring compliance with evolving audit strategies and executing key audits.
Responsibilities
- Lead a global team of Clinical QA Program Leads and drive cross-functional partnerships in a highly matrixed organization
- Drive and deliver audit strategies/capabilities across all GCP audit types
- Conduct GCP audits & support GxP Audits including resolution of CAPAs when applicable
- Serve as the primary contact for Clinical QA related to HA Inspections
- Mentor Clinical QA team members to support talent development and training
- Take an active role in, and lead, projects and teams in key project initiatives across the organization
Requirements
- 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
- 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
- A 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)
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 period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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