Johnson & Johnson Careers

Deliver Quality & Compliance Manager - Bridgewater, MA

Bridgewater, Massachusetts
Quality Assurance


Job Description

Requisition ID: 7697190214

Johnson & Johnson Health Care Systems, a member of the Johnson & Johnson Family of Companies, is hiring a Deliver Manager of Quality and Compliance position at its Logistics Center located in Bridgewater, MA.

Johnson & Johnson Health Care Systems Inc. (JJHCS) provides contracting, supply chain, business services, and strategic solutions to customers and commercial intermediaries of U.S.-based Johnson & Johnson companies, including hospital systems, health plans, distributors, wholesalers, purchasing organizations, government payer programs, and government healthcare institutions in the U.S. JJHCS also engages with customers to provide streamlined supply chain services for our products that seamlessly integrate with customer operations, address shared evolving market challenges to value-based care, and develop innovative solutions that improve patient care and access. *CareAdvantage, Johnson & Johnson Family of Companies, is offered through Johnson & Johnson Health Care Systems Inc. Its Supply Chain Optimization capability is provided for Johnson & Johnson Medical Devices Companies products.

The Manager Quality and Compliance are responsible for the oversight and execution of Quality and Compliance programs at Bridgewater Distribution Center site located in Massachusetts. These positions serves as a single point of contact to Quality and Supply Chain partners, and the Deliver Leads on Distribution Quality related matters. This position will support the Depuy/Synthes Orthopedic Joints franchise to drive timely resolution of Quality related issues. These positions finds opportunities to continuously improve quality, compliance, cost and time factors, consistent with Enterprise, Sector and Deliver business objectives; identifies significant business issues, prioritizes for action, and leads improvement opportunities and problem solutions. The Mgr. Q&C plans, coordinates, and directs quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

• The Manager of Quality & Compliance is responsible for quality oversight of Quarantine/hold/stop-ship/recall processes within the Logistics Center; is responsible for quality oversight of pick/pack/and ship operations, including trending of pick/pack/ and ship errors; is responsible for inventory Quality management, including lot reconciliation within the DC; and is responsible for ensuring returned product is dispositioned according to pre-defined agreements with Operating Company, Franchise, or Marketing Co. Also, this manager is responsible for resolving discrepancies in a timely fashion with appropriate partner.

• The Manager of Quality & Compliance will be responsible for: quality oversight of returns and repack/re-label processes; for quality oversight of monitoring of temperature controlled environment (temperature and humidity as required); quality management and oversight of temperature control shipments (outgoing); quality oversight of the investigation of temperature control excursions and subsequent remediation activities; quality oversight of current work instructions in the Logistics Center.

• This Manager will also be responsible for: quality oversight of change control process; quality oversight and monitoring of calibration and preventive maintenance systems; quality management of service related complaints, including tracking and trending; CAPA, NC, Audit Observation resolution and metric reporting as applicable; conducting internal Quality audits of the LC (schedule, plan, conduct, and follow up); conducting audits of suppliers associated with the LC as required; the management of all internal (JJRC) and external Health Authority inspections (e.g. VAWD, FDA, TUV/BSI) as well as any other logistics and transportation related inspections (e.g., TSA) conducted at the Logistics Center.

• The Manager of Quality & Compliance will play a key leadership role in developing and executing the strategic plan for the Raynham Distribution Center, as well as potential regional sites on a as need basis. This in alignment with the Medical Device Franchises as well as the NA MD strategic plan in accordance with the Supply Chain, ONE MD and Deliver strategies. Additionally, this manager is responsible for carrying out managerial responsibilities in accordance with the organization's policies and applicable laws; including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems.

• For third parties, the Deliver Mgr. of Q&C is responsible for assuring a robust quality management program in place to lead the quality practices and appropriate level of skills for quality personnel at the 3PL’s; ensures appropriate distribution supplier quality management processes in place; ensure appropriate internal-external Quality Agreements are in place.

• This position will also be responsible for coordinating and maintaining current state licensure for the LC.

Qualifications
• A minimum of a Bachelor’s degree is required.
• A minimum of 5 years’ experience in a FDA/GMP regulated industry is required
• Direct working experience with GMP procedures in the manufacturing of medical devices and/or pharmaceutical combination products is highly preferred; will consider Consumer experience.
• Knowledge of Process Excellence tools or Six Sigma methodology a plus.
• Working knowledge of FDA and ISO Quality System Regulations (QSR) required.
• Experience working directly with external regulatory agencies/audits is required.
• Strong collaboration and partnership experience required.
• Ability to influence decisions required.
• Experience with indirect or direct people management is required.
• This position will be located in Bridgewater, Massachusetts and may require up to 25% travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-Massachusetts-Bridgewater-
Organization
Johnson & Johnson HCS Inc. (6077)
Job Function
Quality Assurance
Requisition ID
7697190214