VP Compliance, Regulatory, Quality-Manufacturing
3 days ago
On behalf of a client in the East End of Toronto, I am sourcing a Vice President, Compliance, Regulatory & Quality, to join their Leadership team in the Manufacturing Industry.
Role Description
This is a full-time on-site role located in East End Toronto, Ontario. or a VP Compliance, Regulatory, Quality-Manufacturing. The role involves overseeing all aspects of compliance, regulatory affairs, and quality assurance within the manufacturing process. The Vice President will develop & implement comprehensive compliance programs, provide strategic guidance and leadership on compliance matters. The VP will execute the quality system within all aspects of quality assurance and quality control for finished products and manufacturing process for the company. The successful incumbent will develop the ongoing regulatory strategy and submissions in compliance with all applicable regulatory requirements and in alignment with company goals.
Qualifications
- Demonstrated best practice leadership savvy and promoting an engaging work environment
- Bachelor's degree in Science.
- Extensive experience in compliance, regulatory affairs, and quality control in a manufacturing setting
- Minimum of 8-10 years of relevant experience in a GMP and cGMP manufacturing environment in the pharmaceutical and Natural Health Products industry.
- Superb knowledge of statistical methods and tools for quality improvement.
- Superb knowledge of industry standards and regulations
- Excellent communication and interpersonal abilities
- In-depth knowledge of industry standards (e.g. HC GMP, ICH, CGMP, GLP).
- Ability to interpret and understand application requirements and regulations
Responsibilities
- Strategic thinking and problem-solving skills
- Bachelor's degree in a relevant field, advanced degree preferred
- Certifications in quality management or regulatory affairs is a plus
- Ensure inventory is complete and accurate and distribution and traceability log are maintained properly, updated and are correct.
- Support the preparation and review of validation protocols and reports including transportation, temperature mapping, and stability or freeze-thaw studies.
- Ensure all the staff are trained properly by qualified trainers, trainings are documented and maintained, and the training is verified for effectiveness. Supervise that the environmental monitoring program is performed properly.
- Ensure that products received are transported, handled, sampled, stored, and destroyed in accordance with requirements and correctly.
- Manage sample tracking, label assessments and reviews
- Supervise and monitor labeling and packaging material usage and storage
- Review and approve documents of high complexity including manufacturing validation protocols and reports, master batch records and investigations
- Support and follow-up of product out-of-specification investigations
We thank all those interested in applying. Interested candidates can submit their resumes online or via EMAIL with VP and your Name IN THE SUBJECT LINE OF YOUR EMAIL to joanna@jrhrinc.com We will be contacting candidates closely matching the requirements, skills and experience as outlined in the job description.
We are committed to upholding all applicable legislation and will work with applicants requesting accommodation at any stage of the recruitment process. If you need assistance or require accommodation please contact joanna@jrhrinc.com
We are an equal opportunity employer, valuing respect for one another and among all who work here. We seek to empower each individual, and support the diverse cultures, perspectives, skills, and experiences of our workforce. We are committed to building a team that represents a variety of backgrounds and diverse work experiences as we continue to build an inclusive environment for all employees.
No Agencies Please
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