Job Description

Responsible for the management of the QC laboratory to ensure daily effective cGMP compliant laboratory Systems and Processes covering QC logistics, Microbiology, EM Monitoring, pre-analytical and post-analytical Operations including oversight of subcontracted laboratory work.

Manage daily cGMP operations of:
- Analytical Group that is responsible for the testing of raw materials, intermediate products (IPC) and final drug products,
- Microbiology team that is responsible microbiology testing and reporting of in-process, intermediate and finished product samples and EM samples,
- EM Monitoring group that is responsible for the execution and reporting of EM program on site,
- Logistic group that is responsible for the support of the Quality Control Laboratories, including Sample, Plasma and Data Management as well a is Instrument management (calibration and maintenance),
- Continuous Improvement and optimization,
- Validation and transfer of all laboratory's analytical methods,
Ensure GMP compliance of the laboratory Systems covering pre-analytical, analytical and post-analytical operations.

RESPONSIBILITIES:
1. Ensure development and implementation of department policies and procedures.
2. Deploys and promotes the corporate Values of the Organization across the QC laboratory.
3. Responsible for respecting the yearly laboratory budget and management of key programs (training, QC equipment renewal, etc.) Ensures QC laboratory technology and equipment are qualified, maintained and meet cGMP requirements, including cleaning and maintenance procedures are correctly followed and up to date.
4. Ensures laboratory master documentation and records are maintained as per GMP requirements and also maintained to prevent data integrity issues.
5. Reviews and approves protocols, reports and SOPs related to microbiology and EM groups (i.e. protocols, reports, analytical methods, analytical test reports, periodic STR EM reports) prepared in accordance with appropriate pharmacopeia and/or regulatory guidance;
6. Ensures personnel training on industry guidelines and other pertinent regulatory requirements and ensures QC training meets the internally established standards
7. Ensures laboratory systems and processes are meeting cGMP requirements in preparation for any regulatory inspection (equipment, personnel, micro and EM testing, sample management, data integrity, excel sheets, GMP compliance of related QC programs such as LIMS, EMPOWER, standards and controls, wastes, shipping).
8. Generates, reviews and approves protocols, reports and SOPs related to QC department according to cGMPs requirements and also any inter-departmental documentation (e.g., submission update);
9. Defines laboratory key metrics (QC KPIs and dashboard) to monitor laboratory performance, incl escalation/communication/presentation to Site Quality Council and corporate Senior Management;
10. Responsible for the central laboratory result management process (incl in LIMS) for in- process/intermediate/finished product and raw materials (incl in LIMS) in collaboration with QA for the release of CoT, CoA as per procedures;
11. Responsible for cGMP compliant stability laboratory program (for raw materials, intermediate products (IPC), final drug products, and specific materials e.g., reference standards, buffers);
12. Manages QC laboratory self-inspection program in collaboration with QC Supervisor Logistics,
Analytics, Microbiology and EM Monitoring and supports site internal audit program applicable to QC laboratory groups;
13. Management of reference standards, standards and other critical reagents and outsourced testing;
14. Performs/reviews out-of-specifications (OOS) and failure investigations (OOL, OOT) including CAPA plan;
15. Involves in regulatory filings to Health Authorities (e.g., US FDA) by writing or reviewing the associated sections of INDs, BLAs and MAAs;
16. Responsible for personnel management (e.g., hiring, annual Employee Contribution Appraisal, overtime approval, etc.)
17. Uses scientific expertise to provide assistance for troubleshooting, lab investigations and problem resolution and ensures proper and timely execution of operations.
18. Manages the testing performed by external laboratories for the PBP laboratories.
19. Participates to internal assignments and regulatory audits as required and ensure overall laboratory inspection readiness and risk management (regulatory, quality, compliance, EHS)
20. Promotes development of the teams under his supervision (coaching, mentoring, counseling). Identifies and prioritizes tasks of his direct reports.Other related duties/responsibilities as required or assigned by the hierarchy.

QUALIFICATIONS:

• Master's degree in Analytical Chemistry/Biochemistry or related field with at least eight (8) years or B.Sc. degree with at least ten (10) years of relevant experience in the biotechnology or pharmaceutical industry, with at least two (2) years of supervisory experience.
• Experience with application of compendial methods and microbiology testing and EM program
• Good computer skills (MS Office).
• Able to work independently with minimal guidance in a fast-paced environment
• Solid knowledge of methods used in protein analysis and characterization (ELISA, assays, chromatography, spectrophotometry, electrophoresis, etc.) and raw material testing relating to the manufacturing of biologics.
• Excellent knowledge of operating within a quality management system

OTHER REQUIREMENTS:

• Good verbal and written communication skills in English and French
• Very good organizational and communication skills
• Proven management, strong leadership and interpersonal skills to effectively lead, influence, collaborate and work with diverse teams and individuals at all levels throughout the organization.
• Team spirit, including effective partnership with Quality Assurance, Validation and Manufacturing

teams (Production, Maintenance/ENG, Materials Management, Manufacturing Sciences)

• Strong analytical and critical mind

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MONTRa?AL, TORONTO, VANCOUVER, OTTAWA

HEAD OFFICE

360, St. Jacques, Suite G-100
Montreal (Quebec) H2Y 1P6

A 2019 Groom & Associates. All rights reserved.

A 2018 - 2019 Groom & Associates. All rights reserved.

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