Description
As our Director, Quality amp; Compliance, you are critical in delivering our super premium organic products to provide an incredible consumer and patient experience. You will lead the execution of our QA programs, ensuring a Quality culture across the entire organization. You and your team uphold the highest quality standards while ensuring compliance with Health Canada.
We are looking for a strong, dedicated Director of Quality amp; Compliance who wants to leave a tangible legacy:
- Lead amp; partner with the Operations team to meet production process and product quality standards to ensure the highest quality product
- Release and approve each batch of high-quality product prior to its sale to clients
- As a member of the Operations leadership team, role model the mission, vision and values of the company, and lead the team to exceed expectations so that all our stakeholders share in the extraordinary value that we create.
Responsibilities:
- Ensures that all site practices and strategies align with applicable standards (ex. GPP, GDP, GACP, IMC-G.A.P, EU-GMP etc.)
- Ensures that company processes are aligned with producing superior quality products that delight our customers
- Ensures successful site quality audits, inspections, and associated reports and participates as the SME on global quality and operational controls
- Is the primary point of contact for addressing audit questions and ensuring SME are prepared to address auditor questions
- Leads efforts to improve quality and operational processes to improve performance metrics
- Develops and delivers the education curriculum for training teams on quality and operational controls
- Establishes and delivers quality metrics designed to demonstrate the status of product Quality (Annual product Review)
- Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
- Maintains and improves product quality by enforcing quality policies and procedures and government requirements; completing product, company, and system audits; investigating customer complaints
- Leads management of risks, change controls, preventive controls and hazard analyses, establishes critical limits, monitoring procedures, corrective actions, and verification procedures
- Provides oversight of performance for all Quality and Compliance personnel
- Maintains quality staff by recruiting, selecting, orienting, and training employees
- Conducts activities to assist in qualifying new suppliers and service providers
- Be part of Health Canada inspections. Follow up on observations from audits and inspections and ensure compliance with standards
- Ensure batches are reviewed and released (when permitted) according to all applicable standards and regulations
- Lead the Quality Management System
- Other duties as assigned
- Authority: All authority required to perform the duties and responsibilities of this position are granted to the Director, Quality and Compliance. With the exception of the CEO, Responsible Person (RP), the CFO, and the VP of Operations, no other position can abridge or rescind the authority of the Director, Quality and Compliance to execute the duties contained in this Job Description.
Requirements:
- 5-10 years of experience in a quality position within, pharmaceutical, and natural health product
- 5-10 years’ experience leading a Quality team
- Experience developing and leading continual improvement of a cGMP quality management system, and EU-GMP. Understands applicable standards (GPP, GDP, GACP, IMC-G.A.P, EU-GMP etc.)
- Experience in quality control operations with a producer regulated by the Food and Drugs Act; agri-food processing, pharmaceutical and/or other industries that are certified HACCP Canada
- Strong leadership skills
- Reputation for having strong cross functional relationships throughout the organization
- Strong verbal and written communication skills. Must be able to communicate effectively with numerous stakeholders
- Proven analytical amp; creative thinking, and adept at solving problems
- Proactive; able to anticipate issues. Can keep up with changing priorities in an extremely fast paced environment
- Minimum Bachelor’s degree in Pharmaceutical Sciences or related field
- Must have the ability to obtain security clearance.