Director, Quality Control

at  Resilience

A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit
www.resilience.com
Position Summary:
The Director, Quality Control is accountable for the overall management of QC Chemistry and QC Raw Materials operations at the site in the execution and completion of sample testing using both internal and external contract laboratories to support incoming raw material and component disposition, in-process and final product testing, RBI site utilities, equipment and environmental controls, validation sample testing and client stability project requirements.
This role will ensure that all operations are conducted in compliance with cGMP regulations, relevant compendial requirements, company policies, standards and procedures and safety standards, and that lab systems and resources are appropriately organized and managed to support accurate and timely completion and approval of results, validations, or transfers to ensure client, customer and project needs are delivered in the most efficient and optimal manner.

Position Responsibilities:

• Manage and direct the overall site Quality Control laboratories to deliver accurate and timely testing results
• Direct the implementation and consistent execution of controls for data integrity, documentation, sample management, reagent and reference standard management, instrument and equipment management controls.
• Develop and maintain a high skilled and agile team of analysts and personnel to support optimal service delivery and maintains of high levels of compliance and inspection readiness
• Manage and direct site implementations, in coordination with Resilience Digital and Central Product Quality and Lab Operations Excellence, of key laboratory management systems including LIMS, ELN, CDAS, and reference standard management tools
• Partner with Digital Quality to ensure implementation of the requisite controls to assure data integrity
• Ensure adequate review and approval of instrument and method qualification/validation and transfer protocols and reports, ensuring that the appropriate quality standards have been incorporated and affirmed during the execution of these studies.
• Manage, in collaboration with all stakeholders the QC activities that affect production and validation activities. Anticipate and resolve issues to attain required deadlines and ensure continual communication of status
• Manage the Deviation program process within the laboratories that ensures thorough and timely investigations are completed to correctly identify root cause and develop and implement robust and comprehensive CAPA that is commensurate with risk
• Administer appropriate escalation of critical events to Senior Leadership and ensure close communication with client on quality issues potentially impacting their product or process.
• Review and mentor personnel involved in investigations for critical and major deviation reports, establishment of root cause and development of CAPA within the Quality Management Systems
• Review CAPA for deviations, LIRs and OOSs as required including CAPA Effectiveness Checks
• Interface directly with client stakeholders for quality or compliance issues associated with lab operations and testing
• Oversee and manage lab change control program; review and provide input to change controls
• Oversee compendial review program to ensure site methods align with current compendia and ensure adequate assessment of potential impacts to qualified methods is assessed as part of this review
• Review and approve SOPs as required
• Oversee and manage departmental performance and quality metrics
• Develop and mentor staff
• Stay current and up to date on evolving compliance, regulations and best practices relevant to our industry
• Report Health and Safety incidents, accidents or potential hazards.
• Actively participate in Resilience Communities of Practice to share and adopt best practices
• Prepare and manage departmental budgets, monitor and control spend
• Assist Project Management in developing resource and cost structures for client project proposals and statements of work
• Performs all other related duties as assigned

Minimum Qualifications:

• Significant experience in a Supervisory/Managerial role in Quality Control
• Technical background, direct experience and understanding in any of the following: HPLC/UPLC, ELISA, Kinetic binding assays, icIEF, molecular based assays such as sequencing and PCR, cell-based bioassays., spectrophotometric assays, FTIR, Raman, particle sizing by DLS, molecular sizing by MALLS
• Technical background understanding of analytical methods and method validation including technology transfers
• Demonstrated, well developed analytical and problem-solving skills
• In depth knowledge of requirements of GxP Regulations and guidance of Health Canada, US-FDA, EU in particular data integrity and various compendia (USP, EP, JP)
• Technical understanding of instrument, computerized systems and method validation
• Detail focused and strong attention to detail and accuracy
• Strong presentation skills
• Adaptable and flexible in response to a dynamic operating environment

Preferred Qualifications:

• University Master’s degree in Science with a major in Life Sciences, Biochemistry, Chemistry or Pharmacology with substantial experience in GxP positions with progressive experience in Biologics/Biopharmaceutical/Pharmaceutical industry or Ph.D degree with significant in GxP positions
• Strong understanding of product stability program requirements and development
• Strong understanding of statistics supporting analytical assays, trending and stability programs
• Track record of achievement in ensuring lab execution efficiency and consistency including LEAN concepts
• Experience with industry specific computerized applications including design and implementations (e.g. Veeva, Lab instrument applications, LIMS and ELN)
• Experience in interacting with Regulatory Inspectors/Investigators inclusive of developing Regulatory responses and dossier sections
• Experience in teaching, mentoring and assisting others in learning

This position may also include the following conditions:

• Pre-employment medical and medical re-examination performed every 2 years or as per RESILIENCE’s SOPs
• Job may require flexibility in work schedule to support the operations

The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $145,000.00 - $205,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

• Manage and direct the overall site Quality Control laboratories to deliver accurate and timely testing results
• Direct the implementation and consistent execution of controls for data integrity, documentation, sample management, reagent and reference standard management, instrument and equipment management controls.
• Develop and maintain a high skilled and agile team of analysts and personnel to support optimal service delivery and maintains of high levels of compliance and inspection readiness
• Manage and direct site implementations, in coordination with Resilience Digital and Central Product Quality and Lab Operations Excellence, of key laboratory management systems including LIMS, ELN, CDAS, and reference standard management tools
• Partner with Digital Quality to ensure implementation of the requisite controls to assure data integrity
• Ensure adequate review and approval of instrument and method qualification/validation and transfer protocols and reports, ensuring that the appropriate quality standards have been incorporated and affirmed during the execution of these studies.
• Manage, in collaboration with all stakeholders the QC activities that affect production and validation activities. Anticipate and resolve issues to attain required deadlines and ensure continual communication of status
• Manage the Deviation program process within the laboratories that ensures thorough and timely investigations are completed to correctly identify root cause and develop and implement robust and comprehensive CAPA that is commensurate with risk
• Administer appropriate escalation of critical events to Senior Leadership and ensure close communication with client on quality issues potentially impacting their product or process.
• Review and mentor personnel involved in investigations for critical and major deviation reports, establishment of root cause and development of CAPA within the Quality Management Systems
• Review CAPA for deviations, LIRs and OOSs as required including CAPA Effectiveness Checks
• Interface directly with client stakeholders for quality or compliance issues associated with lab operations and testing
• Oversee and manage lab change control program; review and provide input to change controls
• Oversee compendial review program to ensure site methods align with current compendia and ensure adequate assessment of potential impacts to qualified methods is assessed as part of this review
• Review and approve SOPs as required
• Oversee and manage departmental performance and quality metrics
• Develop and mentor staff
• Stay current and up to date on evolving compliance, regulations and best practices relevant to our industry
• Report Health and Safety incidents, accidents or potential hazards.
• Actively participate in Resilience Communities of Practice to share and adopt best practices
• Prepare and manage departmental budgets, monitor and control spend
• Assist Project Management in developing resource and cost structures for client project proposals and statements of work
• Performs all other related duties as assigne