Compliance Director - Healthcare jobs in Worcester, MA

Associate Director, Manufacturing Training

Summary

Reporting to the Head of Operations MFG11, the Training lead will play a key role in planning, management, and implementation of compliance-related and technical training within the Manufacturing group. This role will act as a key point of contact with the Operations Department Training team ensuring accuracy and compliance of Manufacturing training KPIs, training curricula, and records. During our start-up phase, this role will be crucial in overseeing and ensuring continuous improvement in the training of new Manufacturing staff in Bioprocess associate roles.

Responsibilities

• Key member of the Manufacturing Operations team for MFG11. Will play an important role in the Manufacturing technical and compliance-related training strategy, planning, and implementation.
• Develop Learning and Development strategies and an annual training plan to support the Manufacturing Department's priorities and needs.
• Conduct orientation training for the new technicians and mentor them till they are competent to perform tasks independently.
• Identify the training needs of the shift team and conduct training to close the training gaps. Assist Shift Leads to administer Job Training Curricula of the shift colleagues to progress toward full required competency on all operation tasks.
• Conduct hands-on training including Standard Operating Procedure (SOP) and Job Training (OJT).
• Assessment of training and knowledge retention during OJT and classroom training sessions.
• Work to source local training services and solutions, assess external trainers in close collaboration with the local business
• Ensure the Training KPIs for the MFG team are achieved.
• Conduct refresher training.
• Coordinate the training needs and schedule with the Environmental Health and Safety Department (EHS) annual Emergency Response Training (ERT).
• Proficient in Master control system and able to manage the training requirements of the Manufacturing Team, which includes coordinating all training activities and facilitating group training for the department.
• Conduct periodic reviews and gap analyses of the Manufacturing team Job Curriculum (JC) with manufacturing leads and make changes as required.
• Manage the training requirements of the department, develop training material, and coordinate training activities within the department.
• Coordinate with other functions for internal and external training arrangements for shift colleagues.
• Participate in safety and quality incident investigation to identify opportunities for continuous improvement to training-related gaps.
• Plan and Schedule training for shift colleagues including their off/rest days.
• Preparation of training budget input for Manufacturing. Track and monitor budget spending on an annual basis.

• Ensuring continual improvement of all manufacturing documentation (SOP MBRs, OJTs) to ensure they are current, accurate, and clear.
• Communicate training status reports regularly to the Manufacturing Leadership team, as required, at the appropriate level of detail.

• Assist the manufacturing leaders in coordinating the work between the MFG Operations groups and other functional groups to meet the production objectives and timelines.
• Perform all duties by GMP requirements, SOPs, and controlled documents
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Head of Operations.
• Will act as a role model for the Manufacturing function and the wider organization in adherence to the WuXi corporate core values and PROUD culture.

Qualifications

• BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology. A masters level qualification would be advantageous.
• More than 8 years in biopharmaceutical manufacturing, ideally with experience in both upstream and downstream processing.
• Experience in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality systems in terms of deviation, investigation, CAPA, and change control.
• Experienced technical trainer.
• A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
• The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification
• Experience with GMP systems such as SAP, Orchestrate, benchtop equipment, etc.
• A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
• The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

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