Manager External Clinical Supply Quality

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Bridgewater, New Jersey, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Manager External Clinical Supply Quality! This position can be located in New Jersey, Pennsylvania or Beerse, Belgium.

Position Summary:

The Manager, External Clinical Supply Quality, role is responsible for the quality and compliance in the selection, qualification, monitoring and management for external suppliers used for the packaging, labeling, over-encapsulation, and distribution of Investigational Medicinal products. Additionally, this individual will support the coaching and development within the team of employees supporting these functions, as well as continuous improvement for proactive quality and/or business needs.

Key Responsibilities:

• This position will serve as a Quality contact point for the External Manufacturer/Supplier with respect to the J&J product in the External Manufacturer facility. The position holder will have signatory authority for QA in those projects.
• Support or lead the qualification during selection and routine monitoring of suppliers including but not limited to leading clinical audits and the negotiation of Quality Agreements.
• Contributes to the overall development, implementation, and execution of quality systems in support of the external suppliers.
• Provide cGMP compliance support to suppliers by proactive management of quality using risk-based approaches, and supporting the investigation of quality issues and product quality complaints.
• Drive phase appropriate GMP implementation at external packaging and label suppliers in early and late phase development to fulfill the business requirements.
• Builds relationships and collaborates with suppliers and internal stakeholders to drive compliance and continuous improvement initiatives.
• Monitor trends, identify issues, recommend, and implement appropriate actions.
• Maintain and/or approve GMP documentation at suppliers and within Johnson and Johnson including but not limited to supplier account records, audit records, investigations, and CAPAs.
• Leads or serves in teams or major cross-functional project initiatives to proactively improve quality/compliance or drive business goals.
• Develop, implement, review and/or approve SOPs associated with clinical packaging and labeling
• Oversees the batch record review process and monitor the status of KPIs. Collaborates within Clinical Supply Chain to resolve batch record discrepancies or errors as it relates to Good Documentation Practices.
• Ensure that manipulated drug products and finished products produced for clinical trials are released in accordance with the cGMP and the product specification file and in a timely manner to prevent patient or trial impact.
• Remain current with EMEA/FDA and local GMP regulations, guidelines, and quality practices associated with the pharmaceutical industry.
• Apply cGMP regulations and other FDA/EMEA and international requirements to all aspects of the position.
• Maintain compliance with all company policies and procedures.

Qualifications:

Education:

A minimum of a Bachelors or equivalent University Degree is required with a focus in Science, Engineering and Technical subjects preferred.

Required:

• A Minimum of 8 years of experience within Pharmaceuticals or in an equivalent regulated environment.
• A Minimum of 4 years of experience within Quality.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent analytical skill to ident