Director, Compliance

Role Overview

• 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 Shockwave, Abiomed and V-Wave.
• 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.
• 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.
• Supports supplier/EM compliance activities through the review of supplier audit reports and follow-up reports.
• Participates in early engagement activities with stakeholders.
• 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.
• Serves 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.

Requirements

• A minimum of a Bachelor’s degree is required.
• A focused degree in science, engineering, or equivalent is highly preferred.
• A minimum of 8-10 years of relevant work experience.
• 5+ 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.
• Requires 40-50% travel.

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
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year