Director, Regulatory Compliance

Johnson & Johnson Innovative Medicine • Irvine, CA

3d • $150,000 - $258,750 • Onsite

About The Position

The Director, Regulatory Compliance is responsible for tactical and strategic compliance support to the Johnson and Johnson's regulatory compliance (JJRC) organization. This role provides regulatory compliance expertise and has independent compliance oversight to ensure regulatory standards are met. This role is responsible for leading and executing JJRC follow-up activities related to independent audits such as PAA’s and routine ERC audits, supplier/EM compliance assessments as needed, significant inspections, field actions, and health authority actions, as well as ensuring inspection readiness at high-risk sites. This role is instrumental in helping to identify, escalate, and mitigate risks. This position reports solid line to the Sr. Director Regulatory Compliance, within the Johnson and Johnson Regulatory Compliance (JJRC) organization.

Requirements

• A minimum of a BS is required.
• A focused degree in science, engineering, or equivalent is highly preferred.
• A minimum of 10 years of progressive experience in the pharmaceutical/medical device/biotech industry.
• Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
• Expert and broad-based knowledge of Quality System regulations, ISO, ICH, PIC/S, and GMP regulations.
• Experience performing GXP audits.
• Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
• Ability to resolve complex regulatory compliance issues.
• Ability to analyze and interpret scientific and technical journals, and legal documents.
• Proven success in strategy development and project management, building consensus across broad geographies and business segments.
• Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood.
• Ability to effectively present information to executive management.
• Ability to drive successful program management and build strong cross-functional relationships.
• Ability to influence, negotiate, and build credibility to enable achievement of mutual goals.
• Strong skills in interdependent partnering to facilitate collaboration.
• Ability to perform work independently and proven experience in driving progress and remaining focused under ambiguous and complex situations.

Nice To Haves

• Advanced Analytics
• Audit and Compliance Trends
• Audit Findings and Recommendations
• Compliance Management
• Compliance Risk
• Confidentiality
• Controls Compliance
• Developing Others
• Internal Auditing
• Investigation Techniques
• Legal Function
• Legal Services
• Mentorship
• Policy Development
• Report Writing
• Tactical Planning
• Technical Credibility

Responsibilities

• Responsible for supporting a robust regulatory compliance program for the worldwide headquarters, manufacturing sites, and R&D sites within Cardiovascular Segment of J&J, which includes Electrophysiology (BW), Neurovascular (NV) and Sustainability Solutions (SS).
• Understands the factors contributing to compliance risk profiles, based on metrics and data analysis and other intelligence (e.g., escalations, regulatory inspection outcomes, etc.), to proactively identify, communicate, prioritize, address/prevent/reduce compliance risk.
• Conducts Follow-up activities for the JJRC independent audit program, field action assessments, significant health authority inspections, and regulatory actions.
• The position provides an independent evaluation of compliance events and trends and assures appropriate reporting and escalation commensurate with policy.
• Provides leadership and expertise to interpret and evaluate audit observations and provides guidance and support to develop risk-based action plans.
• Identifies opportunities for cross-regional/site remediation activities collaborate with Segment Quality and Compliance professionals to develop risk-minimizing strategies.
• Support supplier/EM compliance activities through the review of supplier audit reports and follow-up reports.
• Participate in early engagement activities with stakeholders.
• Assist with escalation and alignment activities associated with supplier/EM outcomes as needed.
• Attends RMB, QRB, and franchise management reviews, as required.
• Provides oversight and compliance review of remediation programs (MCAP/SDCAP/QEP, PAM, etc.).
• Represents Compliance on JJRC Enterprise Forums and provides input to JJRC independent audit plan.
• Ensures partnership with JJRC and other Q&C groups to leverage work / resources to minimize duplication.
• Interprets and communicates current and emerging regulatory and J&J requirements at a global level.
• Partners with Q&C and Enterprise Regulatory Outreach groups to continuously monitor the changing regulatory climate to proactively assess and communicate industry trends and emerging areas with potential impact to compliance programs.
• Serve as a key advisor and subject matter expert for critical compliance activities, including due diligence, mock inspections, regulatory agency interactions, decommissioning, divestiture, Quality System and Compliance Analysis (Q-SCAN) execution, special investigations, and business strategies, as needed.
• Supports Health Authority inspection readiness activities at high risk sites, ensures subject matter expert preparedness, and reviews significant communications with Health Authorities.
• Engages with high risk sites, as needed, to oversee and, if necessary, verify remediation efforts.

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

What This Job Offers

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