Job Description

Works closely with Quality Assurance Management, Quality Assurance Managers and support functions in providing direct oversight and leadership in the support of Late Phase and Commercial Manufacture of Cell Therapy Products according to current Good Manufacturing Practices (cGMPs). Direct department employees, resources and programs to ensure compliance with all regulatory requirements; specifically Good Manufacturing Practice (cGMP), Code of ederal Regulations (CFR), EU Guide to Good Manufacturing Practice, International Conference on Harmonization (ICH), Good Tissue Practices (GTP) and relevant foreign regulatory guidelines for biopharmaceuticals. Ensure compliance of critical functions for the site, monitor, trend and report on all aspects of Quality by working
within the department and cross-functionally with other departments to maintain compliance and meet site/program goals and objectives. Identify, implement and drive quality improvement projects and policies to reflect industry best practices.

• Direct and lead staff in support of the commercial manufacturing, testing, and
  release of Cell Therapy Products in compliance with Regulatory Applications and
  Industry Regulations.
• Direct and lead employees within quality assurance and cross-functionally to
  ensure active maintenance in keeping the site current with changes to GXP,
  including FDA and EU and other relevant foreign regulatory bodies as well as
  guidance documents (ie: ICH, PTC, ISPE, etc.).
• Drive continuous improvement and execute pro-active quality control in site’s
  processes.
• Accountable for ensuring that investigations are completed in a thorough and
  timely fashion in order to meet customer commitments and comply with regulatory
  expectations.
• Ensure appropriate CAPA’s are assigned, executed, and demonstrated to be
  effective with the intended remediation activity.
• Direct and Manage QA support for site quality systems such as Change Controls,
  Investigations, Corrective and Preventive Actions, and Product Quality
  Complaints.
• Lead and participate in site quality and process improvement initiatives, and project teams.
• Provide compliance support, expertise and training for the site. Provide direct and
  immediate support for internal, external and regulatory audits of site.
• Oversee compliance-critical functions including change control, validation and
  compliance and quality improvement projects.
• Develop, implement and approve QA policies and procedures.
• Effectively communicate objectives to all employees.
• Establish and maintain a closed loop management process that drives continuous
  improvement in performance to objectives and fact based decision making
• In collaboration with the site management, set strategic direction for current and
  future product, systems, work practice, and process improvements
• Provide leadership in directing the efforts of management, supervisory and direct
  labor for the QA Department.
• Direct, oversee and participate in the recruitment, selection, promotion, termination
  and performance management of QA personnel.
• Foster a spirit of collaboration, cooperation, honesty, and integrity while remaining
  flexible with customer focus.
• Ensure the quality management systems are implemented to ensure a consistent
  level of quality and compliance in all processes. Monitor and maintain quality
  systems and procedures (SOPs) for adherence to regulatory compliance
  requirements. Focus on driving continuous compliance and quality improvements.
  Develop, implement and approve QA policies and procedures.
• Support the site in compliance-critical functions including Non-conforming Events,
  Laboratory Investigations, Change Control, Document Management and CAPA
  systems and processes.
• Review, approve and perform investigations and provide guidance for CAPA
  related to non-compliance situations using creative problem-solving skills.
• Lead and/or participate on cross-functional teams and projects representing quality
  in positive and compliant manner. Work and interact in a collaborative manner at
  all levels of the organization.
• Develops, coordinates, and follows organizational systems, policies, procedures,
  and follows labor and capacity standards.
• Ability to work in a team environment and independently as required

• Bachelors Degree required and
• 10+ years relevant technical experience and min 7 years Managing people
• BS/BA in Science related field preferred; or combination of relevant Experience & Education

Knowledge / Skills / Abilities:

• Thorough working knowledge of Regulatory Compliance, Quality System
  Management and Quality Assurance principles and practices. Strong knowledge
  of 21 CFR 210 and 211, 21 CFR Part 11, EU Guide to Good Manufacturing
  Practice.
• Experience in the development, streamlining, and optimization of Quality Systems
• Experience with Quality Management Systems i.e. Master Control, LIMS, etc
• Ability to use judgment, clear problem-solving and decision-making skills
• Ability to work under limited supervision and to handle complex problems.
• Excellent organizational and interpersonal skills. Ability to communicate effectively
  with all levels of the organization
• Experience with ISO 17205 requirements preferred
• Proficient in Oral & Written communication skills
• Proficient in Microsoft (Excel, Word, Outlook)
• Travel is required 5-10% , Domestic/International, Daily / Overnight

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

WuXi AppTec requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by January 4, 2022. As required by applicable law, WuXi AppTec will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.

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