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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Latina, Italy, Schaffhausen, Switzerland

Job Description:

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• Cork
• Requisition Number: R-070960
• Latina, Beerse and Schaffhausen
• Requisition Number: R-070906

J&J IM is recruiting for a Manager, External Clinical Supply Quality reporting to the Director External Clinical Supply Quality and to be based in one of the locations where the role has been posted.

Job Responsibilities:

• This position provides Quality Assurance, Compliance and Management oversight for External Manufacturers that are involved in development activities and production of clinical batches for all Synthetics (DS & DP)

• Is responsible for the introduction of New Products at external partners and will drive the quality activities from first in human studies through to clinical phase 3.

• Drives Quality Assurance, Compliance and Technical Support for external manufacturers used for the manufacturing of Investigational Medicinal products.

• Supports the transfer process in late phase development to the IMSC organization.

• Supports the selection, qualification, monitoring and management of External Manufacturers in EMEA region.

• Contributes to the overall development, implementation and execution of quality systems in support of the external manufacturers.

• Provides quality leadership to business partners.

• Provides strategic direction from a Quality and Compliance point of view for the management of external manufacturers.

• Leads or participates in teams or major cross-functional project initiatives.

QA Responsibilities:

• Provide cGMP direction to contract manufacturers by pro-active management of quality using risk-based approaches.

• Drive phase appropriate GMP implementation at external manufacturers in early and late phase development to fulfill the business requirements.

• Collaborate with business partners globally and align with the TDS strategy.

• Assess current quality systems and recommend improvements to enhance quality and reduce cycle time.

• Monitor trends, identify issues, recommend and implement appropriate actions.

• Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.

• Support the qualification of External Manufacturers and provide quality input during the selection process as a team member.

• Show leadership during regulatory inspections at EM’s and provides follow up on regulatory commitments.

• Develop, implement, and review of SOPs for interactions with External Manufacturers.

• Investigate customer product quality complaints.

• Apply cGMP regulations and other FDA/EMEA and international requirements to all aspects of the position.

• Coordinate change control documentation and approval process at EM.

• Coordinate and negotiate Quality agreement finalization/revision with EM. Drives the transfer process in late phase development to the JSC organization.

• Interface with other functions (DPDS, JJSA, Technical Operations, CSC, QA-CSC, PQM, etc.) in support of External Manufacturing.

• Provide support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and external manufacturing.

• Remain current with EMEA/FDA and local GMP regulations, guidelines, and quality practices associated with the pharmaceutical industry.

Qualification:

o Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry / Technical / Synthesis Process technology / Chemical Engineering Required.

o Advanced degree (MS, MBA) is a plus.

o Lead auditor certification is a plus

Experience and Skills Required:

• Minimum 8 years of experience in an FDA/EMA regulated chemical/ pharmaceutical environment.

• In-depth understanding of pharmaceutical product development, method development, qualification, manufacturing, validation, testing, release and distribution processes.

• Good knowledge and use of electronic quality management systems (Tru Vault, Veeva, COMET, Trackwise etc)

• Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation, legislations related to method development, Clinical Trials and cGMP and GDP regulations (Eudralex, ICH, Ph.Eur., USP, FDA, etc) at global, regional and national levels.

• Have been exposed to Health Authority (e.g. EU and FDA) inspections

• Strong analytical thinking, decision-making and leadership skills. Excellent verbal and written communication skills to negotiate and communicate with external and internal customers and partners

• Significant experience in the development, implementation of quality systems and interactions with contract manufacturers is preferred.

• Experience in aseptic chemical / pharmaceutical manufacturing

• Knowledge of Synthetics manufacturing including DS and DP, both oral and sterile grade.

• Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.

• Ability to manage multiple and/or complex external manufacturers and work independently to meet project objectives and timelines.

• Ability to work within multiple cross functional teams with global composition.

• Team collaboration skills and coaching skills. Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style.

• Strategic thinking capabilities and ability to translate strategy to execution.

• Results-driven leader who commits to stretch goals and delivers results. Sound business skills, balanced decision-maker.

• Ability to build relationships and confidence with suppliers who support J&J

• Demonstrated understanding of regulatory requirements that impact Quality Systems specifically, and external manufacturers and JSC more broadly.

• Ability to balance multiple tasks, objectives, and priorities.

• Problem-solving abilities and issue resolution abilities within regulatory constraints

• Risk management abilities.

• Fluent in English

Required Skills:

Quality Standards

Preferred Skills:

Good Manufacturing Practices (GMP), ISO 9001