Head of QC – Product Testing & Lab Systems
RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.
We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.
RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.
We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.
The Head of QC – Product Testing & Lab Systems 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.
The Head of QC – Product Testing & Lab Systems will ensure that all operations are conducted in compliance with cGMP regulations, relevant compendial requirements, company policies, standards and procedures and safety standards.
The Head of QC – Product Testing & Lab Systems will ensure 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.
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
University Master’s degree in Science with a major in Life Sciences, Biochemistry, Chemistry or Pharmacology with at least 15 years of experience in GxP positions with progressive experience in Biologics/Biopharmaceutical/Pharmaceutical industry or Ph.D degree with at least 10 years in GxP positions
Minimum 7 years’ experience in a Supervisory role in either Quality Assurance or Quality Control
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
Technical background, direct experience and understanding of 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
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
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
May require up to 5% travel for business related meetings
Demonstrated ability to apply the following behavioural competencies on the job:
Teamwork: Working effectively and productively with others to complete projects or achieve batch production and disposition
Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types
Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
Organization and Planning: Utilizing logical, systematic and orderly procedures to meet business and quality objectives
Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people
Problem Solving: Anticipating, analysing, diagnosing and resolving problems
Decision Making: Utilizing effective processes to make timely decisions
Written Communication: Writing clearly, succinctly and in a manner understood by the target audience and client stakeholders
Flexibility: Agility in adapting to change. Ability to work independently
Conflict resolution - Effectively broker solutions to resolve conflicts between individuals and groups.
This job profile provides an overview of the minimum requirements of the job and does not include all the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.
While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).
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.