Johnson & Johnson Innovative Medicine
Regulatory Compliance Leader, Large Molecule/Advanced Therapies
Johnson & Johnson Innovative Medicine, Horsham, Pennsylvania, United States, 19044
Overview
Regulatory Compliance Leader, Large Molecule/Advanced Therapies. 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 involves 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.
Major Duties & 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.
Proactively identify and prioritize risks and provide guidance on the management of those risks while balancing business needs.
Partner with stakeholders to escalate critical risks to the appropriate levels of management.
Execute compliance programs such as Internal Audit and Inspection Readiness activities to ensure platform compliance with internal and external regulatory and statutory standards.
Communicate emerging regulatory compliance issues and trends.
Develop and achieve short term targets and longer-term compliance strategies.
Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices.
Required Qualifications
Bachelor’s Degree.
20+ years of experience in Pharmaceutical or Medical Device Quality Assurance or Quality Operations and/or Regulatory Compliance; or as an Investigator in the US FDA (combined or separate).
10+ years of People Management Experience.
Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context.
Experience in the Pharmaceutical regulated healthcare environment and with Regulatory Agencies (e.g., US FDA, MHRA).
Track record of achieving successful compliance outcomes, remediating issues and supporting regulatory agency inspections.
Ability to build partnerships, manage complexity, and mediate issues; influential leadership to build consensus and impact outcomes.
Experience implementing or managing risk-based oversight programs across multiple businesses.
Executive presentation skills and experience leading direct and indirect teams.
Ability to balance technical understanding of products and processes with compliance perspective and business acumen.
Preferred Qualifications
Bachelor’s Degree.
Direct experience supporting a company under FDA Warning Letter or Consent decree.
Experience working inside a regulatory agency (e.g., FDA, MHRA).
Knowledge of Large Molecules and Advanced Therapies.
Travel & Work Location Travel on the job: Up to 40% domestically and internationally.
Work Location: Raritan, NJ; Horsham, PA; Titusville, NJ — the position may not be performed remotely.
Compensation & Perks The anticipated base pay range for this position is: 173,000 — 299,000 USD annually. The company maintains competitive, performance-based compensation programs. Eligible for an annual performance bonus in accordance with the applicable plan.
Job Details
Employment type: Full-time
Job function: Legal
Industries: Pharmaceutical Manufacturing
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Major Duties & 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.
Proactively identify and prioritize risks and provide guidance on the management of those risks while balancing business needs.
Partner with stakeholders to escalate critical risks to the appropriate levels of management.
Execute compliance programs such as Internal Audit and Inspection Readiness activities to ensure platform compliance with internal and external regulatory and statutory standards.
Communicate emerging regulatory compliance issues and trends.
Develop and achieve short term targets and longer-term compliance strategies.
Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices.
Required Qualifications
Bachelor’s Degree.
20+ years of experience in Pharmaceutical or Medical Device Quality Assurance or Quality Operations and/or Regulatory Compliance; or as an Investigator in the US FDA (combined or separate).
10+ years of People Management Experience.
Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context.
Experience in the Pharmaceutical regulated healthcare environment and with Regulatory Agencies (e.g., US FDA, MHRA).
Track record of achieving successful compliance outcomes, remediating issues and supporting regulatory agency inspections.
Ability to build partnerships, manage complexity, and mediate issues; influential leadership to build consensus and impact outcomes.
Experience implementing or managing risk-based oversight programs across multiple businesses.
Executive presentation skills and experience leading direct and indirect teams.
Ability to balance technical understanding of products and processes with compliance perspective and business acumen.
Preferred Qualifications
Bachelor’s Degree.
Direct experience supporting a company under FDA Warning Letter or Consent decree.
Experience working inside a regulatory agency (e.g., FDA, MHRA).
Knowledge of Large Molecules and Advanced Therapies.
Travel & Work Location Travel on the job: Up to 40% domestically and internationally.
Work Location: Raritan, NJ; Horsham, PA; Titusville, NJ — the position may not be performed remotely.
Compensation & Perks The anticipated base pay range for this position is: 173,000 — 299,000 USD annually. The company maintains competitive, performance-based compensation programs. Eligible for an annual performance bonus in accordance with the applicable plan.
Job Details
Employment type: Full-time
Job function: Legal
Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr