Director, CQV Lead

4 weeks ago

Vaughan, Ontario, Canada BioTalent Canada Full time
Job Title: Director, CQV

We are seeking a highly experienced Director, CQV to lead our Canadian team in providing compliance services to the pharmaceutical industry.

Key Responsibilities:
  • Maintain successful delivery of compliance projects to clients in the designated region.
  • Oversee project budgets, schedules, deliverables, quality, client satisfaction, and regulatory compliance.
  • Maintain contact with clients to ensure customer satisfaction and regulatory compliance.
  • Lead compliance service activities and oversee region-specific activities for compliance consulting, commissioning, and validation.
  • Support business development strategies and activities, such as lead generation, proposal writing, and client presentations.
  • Work with the CQV management team to develop and apply quality practices for all project deliverables and business practices.
  • Perform project audits to ensure all project goals are being met and compliance services are offered as a value-added product to clients.
  • Promote efficiency in staff utilization and manage regional resources to meet project requirements.
  • Track staff assignments, make resource projections, and make necessary adjustments as required.
  • Prepare workload forecasts to support staffing management.
  • Lead, mentor, train, and manage a team of compliance staff assigned to the respective regional office.
  • Generate and perform C/Q/V deliverable activities, audits, and other compliance services as required, to meet project requirements and personal billability goals.
  • Work with potential new and existing clients to initiate projects following current industry practices.
  • Perform strategic and master planning activities to ensure projects are initiated/started on the right foot.
  • Support and deploy technical training programs that assure competency and advancement levels to support corporate goals.
  • Promote a friendly and efficient work environment that rewards achievement, recognizes teamwork, and champions technical advancement.
Requirements:
  • Bachelor's degree in Engineering, a related discipline, or an equivalent technical degree.
  • 10 years (Manager) to 15 years (Director) of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
  • Experience with Cleaning, Processes, Computer Systems, Methods, and other validation activities and processes.
  • Detailed experience in the discipline of GMP/Validation with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA and international Standards and guidance (ASTM, ICH, ISPE, etc.).
  • Demonstrated/recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyos, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.).
Preferred Qualifications:
  • Experience with Risk-Based Approach to Commissioning and Qualification.
  • This position will have up to 50% travel to the site, or as required by the assigned project or sales opportunities.
  • You may be assigned to a client site for an extended time.
  • Overnight travel or staying in the city of the Client's location is possible depending on the assignment.
  • Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
  • You will visit Client sites and will be required to adhere to stated safety rules.
  • This position is a safety-sensitive position.
  • The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other non-administrative areas.
About Us:

BioTalent Canada is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, we provide consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products.

All qualified applicants will receive consideration for employment at BioTalent Canada without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. BioTalent Canada is proud to be an affirmative action and equal opportunity employer.

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