- Expiry Date: 30 September 2021
This role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight for Manufacturing Operations and QC laboratories; ensuring accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.
Knowledge, Skills, and Abilities:
Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
Must provide guidance to other employees in the interpretation of technical/scientific issues
across a majority of the job function and manage development of technical or scientific
initiatives and activities by interdisciplinary teams.
Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.
Must possess an independent mindset and tenacity.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
Confident in making decisions for minor issues.
Routinely recognizes Quality issues and solves problems.
Proposes solutions for complex issues and works with management to resolve.
Follows established procedures and performs work as assigned.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
Ability to interpret results and situations and articulate recommendations for resolution.
Is recognized Subject Matter Expert within the group.
Capable of providing input within the department and cross functional teams.
Provides guidance to other employees in interpretation of complex data.
Builds relationships internally within and with cross functional teams.
Able to recognize conflict and notify management with proposed recommendations for resolution
Contributes to goals within the work group.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Able to write and review reports with clarity and brevity.
Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
Able to effectively multi-task and execute project management skills.
Knowledge of US and global cGMP requirements.
Understanding of aseptic manufacturing processes.
Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
Excellent verbal and written communication skills.
Education and Experience:
B.S. degree required; advanced degree preferred. Minimum 5 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience preferred
Duties and responsibilities:
Supports all activities for the Quality Operations Investigations group.
Provide quality oversight of Manufacturing Operations, QC Chemistry and QC Microbiology.
Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.
Ensure procedures are adequate and confirm appropriateness of raw data.
Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
Ensure site is compliant with global and regulatory data governance and data integrity requirements
Ensure control of systems, processes and product through supporting review and approval of change notices and change control. Review site change controls and ensure appropriate requirements are identified and completed for implementation.
Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.
Assess global standards/policies and emerging regulations.
Ensure the site stability program meets global and regulatory requirements.
Must be skilled in planning and organizing, decision-making, and building relationships.
Able to effectively multi-task.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.