We are seeking an experienced multidisciplined Quality Assurance Manager to manage and direct personnel and activities of Quality Assurance at the company, ensuring company and regulatory compliance relating to the production and distribution of parenteral and sterile finished dosage forms (FDFs) and active pharmaceutical ingredients (APIs). This encompasses compliance in facilities, equipment, personnel, production and lab operations having an impact on the identity, strength, quality and purity of product supplied by the company.
Product quality is assured by designing, implementing and monitoring a robust quality system, utilizing programs that include Quality Risk Management (QRM), internal and external audits, Annual Product Quality Review (APQR)/Assessments and Non-Conformance/Corrective and Preventive Actions (NC/CAPA).
This position reports directly to the company CEO and is responsible for all Quality decisions at the company, including final release for all FDFs and APIs. This position is also responsible for ensuring compliance across a diverse range of regulatory requirements at the company including – APIs, raw materials, biological products, vaccines, medical devices, cell cultures and Natural Health Products.
Directing the Quality Assurance Department
- Review of batch manufacturing and packaging records and release of bulk and FDFs.
- Design and implement a Standard Operation Procedures (SOP) system, incorporating protocols and validations.
- Implement any market product recalls/withdrawals, as applicable, with the regulatory department.
- Sign off on all GMP related documentation.
- Sign off on NC/CAPA and product complaints.
Directing Quality Compliance
- Assess Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Distribution Practices (GDP) compliance risk areas and develop and implement mitigation measures, as required.
- Hosting and/or carrying out internal and external audits, including regulatory agency audits and customer audits, as applicable.
- Ensuring compliance of the site with Health Canada current Good Manufacturing Practices (cGMP) for FDFs and APIs.
- Provide Quality input and support for Drug Master File (DMF) submissions and maintenance of approvals.
- Provide Quality input and support for Abbreviated New Drug Submissions (ANDS) and maintenance of approvals.
- Provide Quality input into Annual Product Quality Review (APQR).
- Maintain Site Master File Site (SMF).
Personnel Organizational Management
- Accomplish quality assurance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, as per company policy.
- Performance planning, monitoring, appraising, and reviewing job contributions.
- Enforcing policies and procedures.
- Responsible for performance management of direct reports.
- Validate quality processes by establishing product specifications and quality attributes together with Engineering, Production and Quality Control; measuring production.
- Determining operational and performance qualifications.
- Writing and updating quality assurance procedures.
Improving Product Quality
- Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits.
- Investigating customer complaints.
- Collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
- Update job knowledge by studying trends in and developments in quality management.
- Participating in professional organizations.
Data Recording and Integrity
- Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions, and re-validations.
- Ensure computer systems are validated and in compliance.
- Implement a Quality Management System (QMS).
Budgets and CAPEX
- Maintain departmental expenses within an agreed budget.
- Review monthly operating costs and output for department.
- Ensure CAPEX is within approved budget and on time.
Safety of Personnel
- Ensure compliance with workplace policies and procedures for risk identification, risk assessment and risk control – Hazard Analysis and Critical Control Points (HACCP).
- Department to identify and report on health and safety risks, accidents, incidents, injuries and property damage at the workplace.
- Department to participate in established committees/teams relating to health, safety and environmental control.
Knowledge and Experience – Required
- Must hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body related to pharmaceutical product manufacture.
- Training in GMPs, Management Supervisory Skills – Strong leadership skills.
- GMP regulatory standards applicable to Canada, and a working knowledge of external regulations and requirements, such as US 21 CFR part 211 and EU GMP guide Part I.
- 10+ years of experience in GMP manufacturing, Quality Assurance/Control/Compliance or similar operational areas in pharma production with:
- At least 4 years of senior management experience required in the manufacture and packaging of parenteral and sterile pharmaceutical products.
- At least 4 years of senior management experience required in the manufacture and packaging of oral pharmaceutical products.
Knowledge and Experience – Desirable
- At least 2 years of senior management experience required in the manufacture and packaging of active pharmaceutical ingredients.
- Implementation of Laboratory Information Management System (LIMS)
- Experience in finance, computerization and human resources.
- CDMO experience preferred.
- MRNA, vaccine experience, or complex parenteral development experience.
- R&D experience.
Interested applicants should submit a cover letter and resume below. The position will remain open until a suitable candidate is selected.