Johnson & Johnson Innovative Medicine · 2 hours ago
Sr. Mgr. Compliance & Contin Improvement
Horsham, PA
Full-time
Hybrid
Senior Level, Lead/Staff
$122K/yr - $213K/yr
12+ years expJohnson & Johnson is a leader in healthcare innovation, committed to improving health for humanity. The Sr. Manager of Proactive Compliance and Continuous Improvement is responsible for overseeing compliance improvement activities and remediation efforts across Small Molecule Platform sites, ensuring effective project management and collaboration with various stakeholders.
Pharmaceuticals
Responsibilities
Provide leadership through partnerships/collaboration with site leadership, SMEs, Process Owners, Innovative Medicines (IM) Regulatory Compliance and key stakeholders, to oversee execution of program management activities for compliance improvements, and if necessary, remediation programs
Use SM platform site data (e.g., audits, inspections, QMS trends, etc.) to identify needs and facilitate the implementation of compliant solutions where appropriate
Partner with IM Q&C risk and proactive compliance to execute data driven improvement and provide insights
Establish, monitor and report on key performance measures to ensure actions are progressing as defined
Prepare routine and ad hoc program updates for platform leadership and stakeholders
Perform assessments of remediation deliverables as needed and required
Collect and review relevant metrics within and outside of the platform
Maintain abreast of regulatory changes through Established IM Q&C processes
Partner with IM PRC to ensure inspection readiness across the platform and oversight to NPI readiness
Develop and implement platform governance and oversight to compliance improvement activities. Work in partnership with IM PRC and IM Q&C Proactive risk management and compliance to maintain visibility and transparency of site compliance, inspection readiness, and NPI readiness
Oversee execution of program management activities for compliance improvement activities and governance/oversight of site compliance performance including inspection readiness
Qualification
Required
Bachelor's degree (BS/BA). A focused degree in science, engineering, or organizational management is preferred
Minimum of 12 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment
Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them
Experience in the identification and management of GxP compliance risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner
Strong background in site-based quality with inspection experience
ISO 31000 Quality Risk Management, ISO 9001 Quality Management Systems, CQA, data analytics and reporting
Strong influencing and negotiation skills
Excellent written and oral communication skills
Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company
Strong decision making and analysis skills
Demonstrated conflict and change management skills
Strategic Thinking – ability to view bigger picture and translate complex issues into solution based answers that drive real and sustainable change
Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner
Flexibility – ability to travel globally if needed
Confidentiality – ability to maintain confidentiality as appropriate
Adjustment – self-confidence and self-control in high pressure environments, effective stress management
Systems Thinker – understanding how process / actions interact and influence other areas within a whole
Preferred
Business Alignment
Collaborating
Compliance Management
Fact-Based Decision Making
Good Manufacturing Practices (GMP)
ISO 9001
Mentorship
Organizing
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Quality Validation
Regulatory Environment
Standard Operating Procedure (SOP)
Tactical Thinking
Technical Credibility
Benefits
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.
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 period10 days.
Volunteer Leave – 32 hours per calendar year.
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
Company data provided by crunchbase