• Snapboard
  • Activity
  • Reports
  • Campaign
Welcome ,

Chat with the recruiter

...Minimize

Hey I'm Online! Leave me a message.
Let me know if you have any questions.

Associate Director, Quality Control

In United States

Save this job

Associate Director, Quality Control   

Click on the below icons to share this job to Linkedin, Twitter!

JOB TITLE:

Associate Director, Quality Control

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Mountain View, CA United States

JOB DESCRIPTION:

OVERVIEW: At Client our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. The Associate Director, Quality Control is accountable for the leadership activities and directing all aspects of the Quality Control laboratory activities, including but not limited to: scheduling, testing, documentation, inventory management, training, method qualification/validation, equipment management, Certificate of Analysis generation, QC data trending analysis, GLP and cGMP compliance, interaction with clients and regulatory agencies. Responsible for building and/or implementing effective laboratory systems, processes, teams, and managing the staff to overcome the daily challenges of our business. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Manage the day-to-day operation of the QC Laboratories (BioAssay and Microbiology) Prioritize workloads and testing schedules to meet client and manufacturing requirements. Assure that laboratory instrumentation is properly qualified per GMP and where required, is GMP/Part 11 compliant. Working with Development as required, develop and qualify new test methods. Assure that existing methods used in the QC Laboratories in Mountain View are properly qualified. Assure consistency in the choice and implementation of test methods and interpretation of test data within and across the site. Assure efficiency in data review and documentation. Working with the QC Leads in Allendale, NJ and/or Mountain View, CA, along with other stakeholders, implement a Laboratory Information Management System (LIMS) and electronic system for managing environmental monitoring data.  Working with MSAT in Allendale and Mountain View along with Operations and other stakeholders, manage Technology Transfer including but not limited to: Writing/reviewing/approving of transfer documents Methods transfer from Development to QC  Methods transfer between sites Process transfer, as required Working with Manufacturing Operations and Development at both sites, provide support for process verification/comparability/qualification/validation documents as required. Working with the Training Group, develop proficiency training for laboratory analysts. Develop, assess, and report on metrics for Quality Control including but not limited to Environmental Monitoring Out of specification results Invalid test results Hire, develop, train, and evaluate QC personnel. Monitor effectiveness of the quality systems (change control activities, deviations and CAPA) for completion of both site and client specific. Evaluate and investigate customer complaints and deviations, initiate and coordinate corrective and preventive actions as they relate to the quality control function or as assigned. Oversees documentation and implementation of the quality system to assure compliance with customer, regulatory requirements and company standards Reduces non-conformities and non-value added processes Inspires continuous improvement through employee empowerment Develops and implements cost reduction programs Develops short and long term strategic plans Manage third party testing labs Review and approve invoices for reconciliation NetSuite. QUALIFICATIONS: Bachelor's degree in Life Sciences or equivalent, advanced scientific degree desirable Minimum of ten (10) years relevant experience in Quality Control Minimum of five (5) years of leadership/supervisory experience Previous experience interacting with FDA Investigators and other Regulatory agencies Previous experience with management of QC Laboratories Understanding of Technology Transfer and method validation Understanding of laboratory instrumentation including: Part 11 compliance, Understanding of and experience with analytical tests and assays used for cell/gene therapy testing including but not limited to Flow Cytometry, cell counting methodologies, safety testing (sterility, endotoxin, mycoplasma) Understanding of lean six sigma principles Clear understanding of compliance regulations 21 CFR 211, 21 CFR 610, 21 CFR 1271, 21 CFR 11, EU Annex 1; FACT Standards; ISO standards as appropriate COMPETENCIES/CANDIDATE PROFILE:  Strong business acumen Relevant IT skills (able to work with Outlook, Visio, Microsoft Project and Excel) Ability to think strategically and tactically (detail-oriented) Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment Analytical and problem-solving skills Strong written and oral communication skills Meeting management/facilitation skills/teamwork Ability to multi-task team is essential Flexible and able to adapt to company growth and evolving responsibilities Ability to manage ever-changing client and business needs by prioritizing, scheduling and delegating tasks, resolve inefficiencies, and re-allocate resources within the confines of the Quality System Creative and compliant thinking for simplification of laboratory processes and paperwork Good inward/outward facing written and oral communication skills Supervisory Responsibility Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving. Directly supervises employees within the Quality Control  Minimum Required Training N/A WORKING REQUIREMENTS: Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen Must be able to handle the standard/moderate noise of the manufacturing facility Environment requires gowning, hair net, safety glasses, gloves, and foot coverings. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate. PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear, balance; stoop, kneel, or crouch. This role is sedentary. An individual may exert up to 50 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods of time. Direct reports QC Associates QC Scientist Microbiology Supervisor Other Duties  Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. SHIFT: Monday-Friday, Day Shift--8AM-5PM

Position Details

POSTED:

Nov 27, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16551648480754152

LOCATION:

United States

CITY:

Mountain View, CA

Job Origin:

OORWIN_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Associate Director, Quality Control    Apply

Click on the below icons to share this job to Linkedin, Twitter!

OVERVIEW: At Client our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. The Associate Director, Quality Control is accountable for the leadership activities and directing all aspects of the Quality Control laboratory activities, including but not limited to: scheduling, testing, documentation, inventory management, training, method qualification/validation, equipment management, Certificate of Analysis generation, QC data trending analysis, GLP and cGMP compliance, interaction with clients and regulatory agencies. Responsible for building and/or implementing effective laboratory systems, processes, teams, and managing the staff to overcome the daily challenges of our business. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Manage the day-to-day operation of the QC Laboratories (BioAssay and Microbiology) Prioritize workloads and testing schedules to meet client and manufacturing requirements. Assure that laboratory instrumentation is properly qualified per GMP and where required, is GMP/Part 11 compliant. Working with Development as required, develop and qualify new test methods. Assure that existing methods used in the QC Laboratories in Mountain View are properly qualified. Assure consistency in the choice and implementation of test methods and interpretation of test data within and across the site. Assure efficiency in data review and documentation. Working with the QC Leads in Allendale, NJ and/or Mountain View, CA, along with other stakeholders, implement a Laboratory Information Management System (LIMS) and electronic system for managing environmental monitoring data.  Working with MSAT in Allendale and Mountain View along with Operations and other stakeholders, manage Technology Transfer including but not limited to: Writing/reviewing/approving of transfer documents Methods transfer from Development to QC  Methods transfer between sites Process transfer, as required Working with Manufacturing Operations and Development at both sites, provide support for process verification/comparability/qualification/validation documents as required. Working with the Training Group, develop proficiency training for laboratory analysts. Develop, assess, and report on metrics for Quality Control including but not limited to Environmental Monitoring Out of specification results Invalid test results Hire, develop, train, and evaluate QC personnel. Monitor effectiveness of the quality systems (change control activities, deviations and CAPA) for completion of both site and client specific. Evaluate and investigate customer complaints and deviations, initiate and coordinate corrective and preventive actions as they relate to the quality control function or as assigned. Oversees documentation and implementation of the quality system to assure compliance with customer, regulatory requirements and company standards Reduces non-conformities and non-value added processes Inspires continuous improvement through employee empowerment Develops and implements cost reduction programs Develops short and long term strategic plans Manage third party testing labs Review and approve invoices for reconciliation NetSuite. QUALIFICATIONS: Bachelor's degree in Life Sciences or equivalent, advanced scientific degree desirable Minimum of ten (10) years relevant experience in Quality Control Minimum of five (5) years of leadership/supervisory experience Previous experience interacting with FDA Investigators and other Regulatory agencies Previous experience with management of QC Laboratories Understanding of Technology Transfer and method validation Understanding of laboratory instrumentation including: Part 11 compliance, Understanding of and experience with analytical tests and assays used for cell/gene therapy testing including but not limited to Flow Cytometry, cell counting methodologies, safety testing (sterility, endotoxin, mycoplasma) Understanding of lean six sigma principles Clear understanding of compliance regulations 21 CFR 211, 21 CFR 610, 21 CFR 1271, 21 CFR 11, EU Annex 1; FACT Standards; ISO standards as appropriate COMPETENCIES/CANDIDATE PROFILE:  Strong business acumen Relevant IT skills (able to work with Outlook, Visio, Microsoft Project and Excel) Ability to think strategically and tactically (detail-oriented) Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment Analytical and problem-solving skills Strong written and oral communication skills Meeting management/facilitation skills/teamwork Ability to multi-task team is essential Flexible and able to adapt to company growth and evolving responsibilities Ability to manage ever-changing client and business needs by prioritizing, scheduling and delegating tasks, resolve inefficiencies, and re-allocate resources within the confines of the Quality System Creative and compliant thinking for simplification of laboratory processes and paperwork Good inward/outward facing written and oral communication skills Supervisory Responsibility Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving. Directly supervises employees within the Quality Control  Minimum Required Training N/A WORKING REQUIREMENTS: Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen Must be able to handle the standard/moderate noise of the manufacturing facility Environment requires gowning, hair net, safety glasses, gloves, and foot coverings. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate. PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear, balance; stoop, kneel, or crouch. This role is sedentary. An individual may exert up to 50 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods of time. Direct reports QC Associates QC Scientist Microbiology Supervisor Other Duties  Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. SHIFT: Monday-Friday, Day Shift--8AM-5PM


Please wait..!!