Job Title: Compliance Manager - Make Asset Management
This position is responsible for managing compliance activities related to Make Asset Management (MAM) within Johnson and Johnson Innovative Medicine as required by Good Manufacturing Practice (GMP). These activities include executive roles in managing change control, non-conformance investigations, compliance auditing, and other related quality system elements.
Roles and Responsibilities
• Provides leadership and direction to the MAM team in respect of specific quality system and or Quality operation elements to ensure business, quality and compliance goals are met.
• Provides leadership in the development and management of Quality through the following actions:
* Supports the Quality Engineering team in coaching and mentoring the MAM team to ensure GMP compliance goals are achieved.
* Partners with other Departments to ensure that non-conformances and Change Controls are completed in an efficient manner.
* In conjunction with the Quality Engineering Team and QA develop and implement systems and procedures for the management of non-conformance investigations as they apply MAM activities.
* Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
* Tracks commitments arising from investigations.
* Through personal expertise, leadership and commitment, provides direction to the MAM team in the development of a culture of quality and compliance.
Requirements
A minimum of 3 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
• Excellent interpersonal skills.
• Ability to operate as part of a team is critical.
• Customer focus.
• Innovative.
• Excellent communication skills both written and verbal.
• Attention to detail.
• Good problem-solving skills.
• Results and performance driven.
• Adaptable and flexible.