Director, Compliance
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Danvers • Massachusetts • United States
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Salary
💰 $150,000 - $258,750 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality System regulationsISOICHPIC/SGMP regulationsGXP auditsregulatory compliancedata analysisrisk-based action planscompliance risk profiles
Soft Skills
excellent written communicationexcellent oral communicationstrategy developmentproject managementinfluencingnegotiationbuilding credibilitycollaborationindependent workproblem-solving