Quality Systems & Continuous Improvement Specialist in Cambridge, ON.
FUNCTION SUMMARYThe Quality Systems & Continuous Improvement Specialist is accountable to the Senior Manager, Quality and is responsible for providing quality and compliance leadership within a cross-functional continuous improvement team. The Quality Systems & Continuous Improvement Specialist will partner with Production, Engineering, Technical Services, Validation, and Quality personnel to identify, prioritize, and implement improvements that enhance manufacturing performance, product quality, and quality system effectiveness.
The Quality Systems & Continuous Improvement Specialist will provide quality oversight and regulatory guidance for continuous improvement initiatives and quality event management activities. This role will lead and support investigations, risk assessments, and corrective and preventive actions (CAPAs) to ensure issues are effectively resolved and improvements are implemented in a compliant and sustainable manner.
Success in this position requires a strong presence on the manufacturing floor, actively observing processes, engaging with operators and technical staff, identifying emerging issues and opportunities, and applying critical, innovative thinking to drive practical and effective solutions. The incumbent will leverage GMP and regulatory requirements using a risk-based approach, balancing quality, compliance, operational performance, and business objectives. In addition, this role will be instrumental in accelerating the maturation of newly implemented procedures and quality system processes, ensuring they are robust, effective, and sustainable components of the organization's Quality Management System.
PRIMARY DUTIES AND RESPONSIBILITIES:- Partner with Production, Engineering, Technical Services, Validation, and Quality teams to identify and implement improvements to manufacturing processes, equipment, systems, and procedures that enhance product quality, process capability, and operational performance
- Maintain a strong presence within manufacturing operations to develop a thorough understanding of processes, identify improvement opportunities, and support sustainable operational and quality excellence.
- Provide quality and regulatory guidance to cross-functional teams and continuous improvement initiatives, ensuring compliance with GMP regulations, industry standards, and regulatory expectations.
- Review and assess proposed process, equipment, facility, and procedural changes for quality and regulatory impact.
- Apply critical thinking, scientific analysis, risk-based decision making, and structured problem-solving methodologies to investigate issues, identify root causes, challenge conventional approaches, and develop effective solutions.
- Lead and/or facilitate investigations related to deviations, complaints, audit observations, environmental monitoring excursions, and other quality events, ensuring investigations are thorough, scientifically sound, and completed within established timelines.
- Lead and/or support the development, implementation, effectiveness verification, and on-time closure of corrective and preventive actions (CAPAs) and other quality event actions.
- Lead and/or facilitate quality risk assessments and ensure quality risks are appropriately identified, evaluated, and mitigated.
- Monitor and trend manufacturing and quality system performance data to identify recurring issues, emerging risks, and opportunities for improvement.
- Lead and support the design, implementation, and maturation of quality systems, procedures, and business processes, ensuring they are effective, compliant, sustainable, and aligned with organizational objectives.
- Partner with operational teams to establish process controls, performance metrics, and feedback mechanisms that drive process capability, consistency, continuous improvement, and operational effectiveness.
- Identify opportunities to simplify processes, improve product quality, process capability, and operational performance, and reduce compliance risk while maintaining patient safety and regulatory compliance.
- Participate in internal and external audits, regulatory inspections, and inspection readiness activities as required.
- Develop and report quality metrics related to investigations, CAPAs, quality events, quality systems, and continuous improvement initiatives.
- Facilitate cross-functional meetings and ensure action items are appropriately assigned, tracked, and completed on time.
- Provide training, coaching, and guidance related to investigation practices, root cause analysis, risk management, continuous improvement, and quality system requirements.
- Demonstrates the company's core values, policies, and standard business practices.
- Performs other related duties as required.
BASIC REQUIREMENTSEDUCATION- A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field, from a recognized academic institution.
- An individual possessing a Professional Engineer (P.Eng.) license is an asset.
EXPERIENCE- Minimum five years' experience in a pharmaceutical, biologics, medical device, or other GMP-regulated manufacturing environment.
- Experience leading investigations, CAPAs, and continuous improvement initiatives.
- Demonstrated ability to rapidly learn and develop expertise in manufacturing processes, deeply understand how systems operate, identify opportunities for transformational improvement, and develop innovative solutions that challenge traditional thinking while improving product quality, process capability, and operational performance.
- Strong knowledge of GMP regulations, quality systems, and risk management principles.
- Experience working within manufacturing, engineering, technical services, validation, or quality functions.
- Working knowledge of Health Canada, FDA, EU GMP, and applicable industry standards.
- Strong facilitation, communication, project management, and problem-solving skills
KNOWLEDGE AND SKILLS- Strong understanding of pharmaceutical manufacturing processes and quality systems.
- Ability to interpret and apply regulatory requirements using a practical, risk-based approach.
- Ability to balance compliance requirements with operational and business objectives.
- Strong analytical and critical-thinking skills.
- Effective collaboration and influencing skills within cross-functional teams.
- Proficiency in root cause analysis, risk assessment, and continuous improvement methodologies.
Compensation
Starting at approximately $94,000.00 CAD with opportunity for increase based on qualifications and experience. Total rewards include comprehensive benefits, bonus eligibility, and professional development support.
What we Offer:- Excellent compensation/benefits package
- RRSP Program
- Discounted gym memberships
- Programs supporting work life balance (EAP)
- Corporate Discounts and PERKS
- Employee recognition program
- Social events and spirit days
