myGwork - LGBTQ+ Business Community
Regulatory Compliance Leader, Large Molecule/Advanced Therapies
myGwork - LGBTQ+ Business Community, Raritan, New Jersey, us, 08869
Overview
Innovative Medicine, Regulatory Compliance, Large Molecule/Advanced Therapies Leader. This compliance leadership role reports to the Vice President, Innovative Medicine Regulatory Compliance Leader, and oversees a team of 15+ compliance professionals as part of the Leadership Team. The position is responsible for regulatory compliance within the Large Molecule and Advanced Therapies Platforms, including Health Authority Inspection readiness and site audits. The role requires leading and developing the compliance team, maintaining a robust program, and collaborating with Quality, Supply Chain, Regulatory Affairs, R&D, and Corporate Compliance partners to support current and future business needs. Company Background & Culture
Johnson & Johnson (J&J) is a multinational health care company with a strong presence in biologics and large molecule therapies, including advanced therapies such as gene therapy, cell therapy, and monoclonal antibodies. The company emphasizes innovation and scientific excellence across the pharmaceutical and medical technologies sectors. Location & Travel
Locations: Raritan, NJ; Horsham, PA; Titusville, NJ. Travel: Up to 40% domestically and internationally. The position may not be performed remotely. Responsibilities
Serve as an expert regulatory compliance advisor and Subject Matter Expert across the Large Molecule and Advanced Therapies Platforms. Provide compliance expertise and a global compliance perspective in the development of preventive risk management strategies. Identify and prioritize risks, provide guidance on risk management while balancing business needs; escalate critical risks to appropriate management levels. Lead and execute compliance programs such as Internal Audit and Inspection Readiness to ensure platform compliance with internal and external standards. Communicate emerging regulatory compliance issues and trends. Develop and achieve short-term targets and long-term compliance strategies. Establish a high-performance, continuous-improvement culture driven by KPIs, benchmarking, and sharing best practices. Required Qualifications
Bachelor's Degree required. 20+ years of experience in Pharmaceutical or Medical Device Quality Assurance/Quality Operations and/or Regulatory Compliance; or as an Investigator in the US FDA. 10+ years of people management experience. Significant experience managing Quality and Regulatory Compliance in an international context; experience with regulatory agencies (e.g., US FDA, MHRA). Track record of achieving compliance outcomes, remediating issues, and supporting regulatory inspections. Ability to build partnerships, manage complexity, and influence decisions without always having line authority. Experience implementing risk-based oversight programs across multiple businesses. Executive presentation skills and experience leading direct and indirect teams to deliver results. Ability to balance technical product/process understanding with compliance perspective and business acumen. Preferred Qualifications
Bachelor's Degree (preferred). Direct experience supporting a company under FDA Warning Letter or Consent Decree. Experience working inside regulatory agencies (e.g., FDA, MHRA). Knowledge: Large Molecules; Advanced Therapies. Compensation & Additional Details
Anticipated base pay range: 173,000 – 299,000 USD per year. Eligible for annual performance bonus per applicable plan. Jointly, the company maintains competitive, performance-based compensation programs.
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Innovative Medicine, Regulatory Compliance, Large Molecule/Advanced Therapies Leader. This compliance leadership role reports to the Vice President, Innovative Medicine Regulatory Compliance Leader, and oversees a team of 15+ compliance professionals as part of the Leadership Team. The position is responsible for regulatory compliance within the Large Molecule and Advanced Therapies Platforms, including Health Authority Inspection readiness and site audits. The role requires leading and developing the compliance team, maintaining a robust program, and collaborating with Quality, Supply Chain, Regulatory Affairs, R&D, and Corporate Compliance partners to support current and future business needs. Company Background & Culture
Johnson & Johnson (J&J) is a multinational health care company with a strong presence in biologics and large molecule therapies, including advanced therapies such as gene therapy, cell therapy, and monoclonal antibodies. The company emphasizes innovation and scientific excellence across the pharmaceutical and medical technologies sectors. Location & Travel
Locations: Raritan, NJ; Horsham, PA; Titusville, NJ. Travel: Up to 40% domestically and internationally. The position may not be performed remotely. Responsibilities
Serve as an expert regulatory compliance advisor and Subject Matter Expert across the Large Molecule and Advanced Therapies Platforms. Provide compliance expertise and a global compliance perspective in the development of preventive risk management strategies. Identify and prioritize risks, provide guidance on risk management while balancing business needs; escalate critical risks to appropriate management levels. Lead and execute compliance programs such as Internal Audit and Inspection Readiness to ensure platform compliance with internal and external standards. Communicate emerging regulatory compliance issues and trends. Develop and achieve short-term targets and long-term compliance strategies. Establish a high-performance, continuous-improvement culture driven by KPIs, benchmarking, and sharing best practices. Required Qualifications
Bachelor's Degree required. 20+ years of experience in Pharmaceutical or Medical Device Quality Assurance/Quality Operations and/or Regulatory Compliance; or as an Investigator in the US FDA. 10+ years of people management experience. Significant experience managing Quality and Regulatory Compliance in an international context; experience with regulatory agencies (e.g., US FDA, MHRA). Track record of achieving compliance outcomes, remediating issues, and supporting regulatory inspections. Ability to build partnerships, manage complexity, and influence decisions without always having line authority. Experience implementing risk-based oversight programs across multiple businesses. Executive presentation skills and experience leading direct and indirect teams to deliver results. Ability to balance technical product/process understanding with compliance perspective and business acumen. Preferred Qualifications
Bachelor's Degree (preferred). Direct experience supporting a company under FDA Warning Letter or Consent Decree. Experience working inside regulatory agencies (e.g., FDA, MHRA). Knowledge: Large Molecules; Advanced Therapies. Compensation & Additional Details
Anticipated base pay range: 173,000 – 299,000 USD per year. Eligible for annual performance bonus per applicable plan. Jointly, the company maintains competitive, performance-based compensation programs.
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