Manager Quality Systems & Compliance

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

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Manager Quality Systems & Compliance

Lead & manages the Quality Systems & Compliance team, proactively developing, improving and monitoring GMP compliance and the applicable guidance on compliance and quality systems across the Leiden site to enable the accomplishment of the company’s goal of providing high quality products to patients, prescribers and partners and compliance with regulations. Is responsible for the electronic Quality Systems that support these compliance programs.

Is responsible for all Core Quality Systems, including Management Review, Inspection Readiness, Auditing, GMP training and Document management. Manages the development of a long-term vision and strategy for these quality systems in close cooperation with the site and translating these strategies into compliant programs and processes in line with regulations and business expectations.

Essential Job Duties and Responsibilities

Management of the department

To manage, lead & motivate the Quality Systems & Compliance department to enhance performance and achieve business goals, agreed metrics & budgets: Performance management; mentor, train, and coach team members Manage workload and resource distribution within and across teams. Manage budget forecast, planning, and monitoring Responsible for interviewing, hiring, and management/employee development cycle of staff To develop, improve and monitor comprehensive GMP compliant Quality core systems to facilitate the production of high-quality products and prevent or reduce the risk of defective products entering the marketplace To ensure that a monitoring and continuous improvement process is developed and implemented to enable effective and consistent use of the quality system across the site.

Quality Systems & Compliance

Act as a knowledge center for Compliance subjects, to ensure that state-of-the-art knowledge and standards are known and rolled out in the organization. Manage the resolution of unexpected complex compliance or quality system issues as they arise Influence and manage regulatory and corporate expectations and relationships to ensure harmonization & alignment of the site’s core quality systems, plans and programs to maintain GMP compliance in the current and future situation. Responsible for site’s Management Review program including the Quality Metrics program, to ensure and proactively enhance compliance and business performance of the site. Manage the development, implementation, and monitoring the effectiveness of GMP Training programs, processes and training execution and administration, to ensure that appropriate training levels are maintained at the site in compliance with regulations and business expectations Manage the development, implementation, and monitoring the effectiveness of GMP Documentation processes and administration, to ensure that appropriate documentation practices are maintained at the site in compliance with regulations and business expectations. Manage the user input, implementation, and monitoring the effectiveness of electronic Quality Systems, to ensure that these electronic systems are fit for use and in compliance with regulations and business expectations

Magnitude & Complexity

Span of control; this position holds the management responsibility of 8-10 direct reports (and 16-25 including indirect reports).

The function requires resourcefulness to initiate innovative, compliant systems & solutions to proactively manage compliance improvements and to manage unexpected complex compliance or systemic issues as they arise. Responsibilities can be complex and diversified involving complex activities or work groups.

This position requires independent thinking and decision-making in complex environments. In day-to-day business there is limited review by others. If the job is not performed correctly, there is a likelihood for a high negative impact on the compliance situation of the site or on product quality.

This position requires proven problem solving & trouble shooting ability to analyze & resolve complex, ad-hoc compliance and/or quality system issues while balancing business, financial and compliance requirements to ensure stability and sustainability.

The function requires staying knowledgeable of the current regulations, and of industry & regulatory trends to identify & interpret global regulatory GMP requirements to maintain center of expertise position in the quality and compliance area.

The jobholder should have working knowledge of and must be able to interpret:

GMPs (US, EU, others) and related annexes. JSC, Pharma and J&J guidelines Marketing Authorizations of products managed by Janssen Biologics (e.g., Remicade, ReoPro, CNTO’s)

To make a compliant translation to the business, this also implies:

• Understanding of the application of technology to improve Compliance & Quality processes
• Understanding of production processes & associated roles & functions and ability to interact appropriately and execute appropriate decisions

The role is to proactively develop and maintain complex stakeholder relationships at all levels with corporate and sister sites, and other outside organizations to ensure harmonization and alignment of quality policies and standards.

The jobholder is expected to act as contact for the site in the area of responsibility. The person can negotiate a favorable solution for all parties involved, even when interests are colliding. (Outside) contacts require excellent communication, influencing and negation skills, diplomacy and demonstrated credibility.

Contacts:

• QA/QC departments. Purpose: to ensure quality programs are set up in an effective, compliant, and efficient manner and the execution is done in line with the regulations and company’s policies and guidelines.
• JJRC. Purpose: to act as interface with JJRC department related to compliance of Quality Systems and to support Inspection readiness activities.
• All GMP departments in the site (Operations, FME, Q&CO sub departments, LO, IT etc.). Purpose: oversight over effective set up and execution of quality programs, such as Management Review, Inspection Readiness, Auditing, Documentation management, Training and general compliance support (e.g., through compliance projects)
• J&J contacts: J&J Corporate Compliance or RA departments and other sister sites. Purpose: to ensure alignment with these sites in the areas of the department’s responsibility, e.g., through the active involvement in global project for the development and roll out of Quality Standards and Quality programs.
• Finance Management. Purpose: for budget management
• HR. Purpose: all aspects of people management

Minimum Qualification

Minimum education required for the position

• University degree (or equivalent) in relevant discipline, e.g., biosciences, pharmacy, analytical chemistry, process technology or engineering
• Knowledge of current Quality Management principles, GMP and Quality Systems regulations

Minimum experience required for the position:

• 10 years’ experience in Quality and/or related Supply Chain Operations, of which 5 years is in a managerial role.
• Significant experience interacting with health authorities.