Sr. Mgr. Compliance & Contin Improvement

Johnson & Johnson Innovative Medicine•Horsham, PA

9d•$122,000 - $212,750

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com The Sr. Manager Proactive Compliance and Continuous improvement has responsibility for supporting the development and management of Small Molecule (SM) Platform sites compliance improvement activities and remediation (as appropriate). The position will work in partnership with the Small Molecule site leadership, Small Molecule regulatory compliance and other Subject Matter Experts both within a site and outside a site to develop compliance improvement solutions and, if necessary, documented compliance remediation plans that include measurable time-based actions/deliverables. The position will administer Project Management processes across the SM platform sites. The position will partner effectively to facilitate deployment of assigned compliance improvement initiatives/programs. This includes tracking plan performance, facilitating actions to address risks, and preparing consolidated / actionable view of risks across the platform and processes.

Requirements

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.

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.
Other activities as required, for example: strategic projects, process enhancement initiatives, Health Authority inspection support

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 period10 days.
Volunteer Leave – 32 hours per calendar year.
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits