J&J Family of Companies VP, Consumer Health Quality and Compliance North America Regional Head in Fort Washington, Pennsylvania
We’re 19,000+ dreamers and doers, driven to improve the health of people around the world every day. We believe in the power of new perspectives and insights to drive innovation. And we know that relentless collaboration is the key to continually improving our products—and inventing new ones. We’re here to help empower people to take care of themselves and their loved ones—and nothing’s more important than that.
Responsible for the E2E regional Quality and Compliance organization and performance.
Responsible for ensuring the overall compliance of the region by establishing the compliance strategies and priorities including overseeing the development of policies and requirements for the Quality Management System based on health authority regulations.
Ensures qualified resources are in place to manage internal and external manufacturing (IM/EM) site compliance and Supplier management compliance. Additionally, this position is responsible for the quality system performance in the region related to R&D and life cycle management of US and Canada products.
Furthermore, this position provides leadership and serves as the single point of contact in Quality for:
Regional Franchise leaders
Regional Supply chain leadership
Regional commercial teams and commercial Leader
Partnering with the above stakeholders to manage and deliver on both the business and Q&C outcome measures.
Specifically, this position serves as the most responsible person for US Self-Care and chairs the Compliance Management Committee providing direction, insight and expectations to senior management related to emerging compliance trends and opportunities in US Self-Care post Consent Decree.
Conduct management reviews for Management with Executive Responsibility; Escalation to Sr. Management of issues potentially impacting product quality, safety and/or compliance to regional regulations. Responsible for the Quality oversight of internal and external manufacturing facilities and Q&C processes of R&D for the North America Region
Oversee processes for quality planning and quality support and oversight for tech transfer and new product validation
Provides oversight to the local/regional market specific regulations. Manages complaint vigilance for the region ensuring integration of the CV process end to end from intake to the product quality complaint, investigation, trending and reporting.
Partners with medical safety, regulatory, compliance and legal departments to ensure timely and compliant management of quality escalations in the region. Leads and directs the regional franchise quality leads to manage regional and / or global escalations.
Responsible for ensuring effective deployment of key quality management system elements including but not limited to quality planning, internal audit, training, document controls, purchasing controls, complaint vigilance, supplier quality, CAPA, and non-conformance management end to end. Ensuring a constant state of readiness for planned and ad-hoc regulatory audits or inspections conducted by regulatory bodies, competent authorities, or other agencies. Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality and compliance.
Ensures deployment of quality systems and standards at the internal and external manufacturing sites and provides oversight of quality systems and standards at the deliver sites in the regions. Performs trending and monitoring of quality and compliance performance at the manufacturing sites in the region and leads implementation of any required mitigation and CAPA plans.
Develops, drives budget, organizational structure, and base business requirements to accommodate business needs. Develops and monitors performance and process metrics. Develops a foundation of highly capable, aligned and engaged Quality professions in NA which maximizes the strengths of its members. Provides direction, oversight, and development of the staff. Assures that an appropriate talent pool is developed and succession planning in place to support current and future business needs.
Communicate with key partners across R&D, Commercial and SC regarding emerging risks to product safety, product quality or compliance. Collaborate with site, regional, global functions to establish the vision and strategies for quality and compliance development and integration in line with applicable regulatory requirements.
Develops and leads the regional quality strategies in line with the Company’s global Q&C strategic direction.
Education: BS (minimum requirement) - MBA or related business degree MA/MS in Pharmacy, Life Sciences (Biology, Chemistry) is preferred.
Minimum required of 15 years Senior level management experience in a regulated medical industry. Related industry experience in Pharma, Medical Device and/or Diagnostics is preferred.
Minimum of 10 years of People Management experience required.
Working knowledge of the business environment inside a quality organization, across various roles (e.g.: quality operations, QC, Quality Systems, pre-production quality assurance, validation, market quality, regulatory etc.).
Experience working under a Consent Decree.
Demonstrated experience leading professionals in a matrixed environment.
Experience with E2E supply chain operations.
Demonstrated ability to lead and deliver strategies.
Proven record to deliver results in a rapidly changing and complex business environment.
“Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health's employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes.”
United States-Pennsylvania-Fort Washington-7050 Camp Hill Road
North America-United States-New Jersey
Johnson & Johnson Consumer Inc. (6101)
J&J Family of Companies
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