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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.

Responsibilities

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.

Regulatory Support

• 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.                                                                                        

Validations/Qualifications 

• 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.

Requirements

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.

With a network of over 100 pharmaceutical scientists, clinicians, regulatory, patent, and market experts, Applied Pharmaceutical Innovation (API) helps bring life-saving research to the real world. API is a not-for-profit institution with an expert interdisciplinary team that works with a network of collaborating organizations to provide the expertise, services, and infrastructure of a pharmaceutical company. API helps innovators launch their ideas into the real world, connect industry to the services they need for commercial success, and accelerate all aspects of the drug development process. API provides industry partners access to translational science in a framework that supports commercial success, as well as provides the services and resources by delivering expertise in drug development.

Position Summary

The Manager, Quality Systems will be responsible for the various quality systems utilized at API. This position will ensure appropriate processes have been developed as well as manage a select number of these processes. The Manager will have oversight of the e-systems utilized at API and will work with cross functional teams to ensure the corresponding programs are in place and compliant. Reporting to the Vice President, Technical and Regulatory, this person will ensure the systems utilized at API will fulfill both internal and regulatory standards as well as client expectations.

Interested applicants should send a cover letter and resume. The position will remain open until a suitable candidate is selected.

PLEASE NOTE: Applications submitted without a cover letter will not be reviewed.

Responsibilities including, but not limited to:

• Oversee the quality systems at API including (but not limited to): lab management (GLP), clinical affairs (GCP), regulatory submissions, importation of health care products, testing, fabrication, package/labeling, and post market (GVP).
• Support API’s Drug Establishment Licence (including GxPs), the Dealer’s Licence, and any other additional licences maintained by API.
• Implement, monitor and continually improve the e-system(s) at API.
• Manage the quality system processes at API including:
• Document and Records Control
• Training/Personnel (non-HR)
• Change Management
• Corrective Action / Preventive Action
• Audits
• Support additional quality systems including (but not limited to): laboratory management (including GLP), calibration / maintenance, purchasing, vendor management, stability, premises, equipment, sanitation, testing, samples, sterile products, validation, vigilance (GVP), recall and reporting.
• Support audits of API (and clients as warranted) including, but not limited to, regulatory agencies, certification organizations, customers.
• Work with management on developing key Quality Objectives and KPIs, monitoring as necessary.
• Work closely with IT to ensure all IT policies are in place and adhered, including control of electronic records including sensitive and GxP data.
• Work with subject matter experts to translate different areas of the product development and manufacturing lifecycle into appropriate quality system processes.
• Assist in developing service estimates around quality systems support.
• Manage documents and records as per the associated regulations and the API quality management system.
• Support periodic activities such as an annual Management Reviews

Requirements:

• Minimum four year degree in a scientific or medical field; pharmaceutical sciences field considered an asset.
• 5 – 7 years of experience in quality system management, preferably under pharmaceutical GxPs.
• Experience with quality systems for drugs is a must, experience with quality systems for medical devices and in-vitro diagnostics is considered an asset.
• Knowledge of pharmaceutical GMPs including (but not limited to): GUI-0001, 21 CFR part 210, 211, 11, ICH Q10.
• Demonstrated ability to lead the development of quality system processes and documents.
• Experience in conducting and/or hosting quality inspections/audits. Certified auditor preferred.
• Familiarity with regulatory inspections from various regulatory bodies, including Health Canada, FDA, and/or European Medicines Agency
• Experience with validated e-systems such as Trackwise, Master Control, Sage, Oracle, SAP, Microsoft Dynamics, Pilgrim etc.(also other e-QMS, LIMS, ERPs etc.).
• Strong Quality communication skills (comprehension, written, and oral); experience in developing Quality policies and objectives, and being a voice for Quality in the organization.
• Ability to multitask and direct multiple areas within the organization.
• Exceptional oral and written communication skills, with a dedication to quality and reliability.
• Flexibility to adapt easily to change in the workplace and changing priorities.
• Excellent computer skills (Microsoft Office Suite/Google Docs, e-systems).

Employment Type: Full-time, permanent

Location: Edmonton, Alberta (in-person)

To Apply:

Interested applicants should submit a resume and cover letter using the form below, detailing their fit for the role and salary-range expectations. Please note that due to a high volume of applications, only successful candidates will be contacted.

With a network of over 100 pharmaceutical scientists, clinicians, regulatory, patent, and market experts, Applied Pharmaceutical Innovation (API) helps bring life-saving research to the real world. API is a not-for-profit institution with an expert interdisciplinary team that works with a network of collaborating organizations to provide the expertise, services, and infrastructure of a pharmaceutical company. API helps innovators launch their ideas into the real world, connect industry to the services they need for commercial success, and accelerate all aspects of the drug development process. API provides industry partners access to translational science in a framework that supports commercial success, as well as provides the services and resources by delivering expertise in drug development.

Position Summary

The Manager, Operations & EH&S will handle a wide range of responsibilities around the operations of API’s plant, warehouse, and lab facilities. This position will ensure day to day operations at API run smoothly including facility operations around the Good Manufacturing Practices (GMP) plant(s) and labs, as well as warehouse and related inventory management. The Manager will also have direct oversight of the EH&S aspects of the organization. Reporting to the Vice President, Technical and Regulatory, this person will ensure the systems utilized at API will fulfill both internal and regulatory standards/code as well as client expectations.

Interested applicants should submit a cover letter and resume below. The position will remain open until a suitable candidate is selected.

Responsibilities including, but not limited to:

• Oversee facility operations related to GMP plant(s) and labs (and additional areas as necessary) (Note: GMP operations themselves will be handled by the GMP manufacturing teams).
• Oversee the environmental, health and safety systems at API locations.
• Oversee the (small) warehousing operation including materials, supplies, and imported products.
• Work with vendors (e.g., suppliers, contractors, transportation companies) to ensure materials and products are received and shipped.
• Work with contractors on projects and maintenance related to the facility.
• Support API’s Drug Establishment Licence, Dealer’s Licence, and any other related licences maintained by API.
• Implement, monitor, and/or continually improve the related e-system(s) at API.
• Manage the inventory of supplies and product (e.g., imported).
• Support audits and/or inspections of API (and clients as warranted) including, but not limited to, regulatory agencies and customers.
• Assist in setting up products and materials to be imported and received.
• Manage documents and records as per the associated regulations and the API quality management system.
• Support periodic activities such as inventory counts and health & safety inspections.

Requirements:

• Minimum post-secondary education in a technical area.
  5 – 7 years cumulative experience in facility operations, warehouse management and EH&S.
• Experience with health & safety including WHMIS and TDG is a must (health & safety certificate considered an asset), experience with controlled substances is an asset.
• Understanding the Alberta Occupational Health & Safety Act, Regulation and Code.
• Familiarity with:
  • facility operations including upkeep and maintenance.
  • warehouse management systems including principles like FIFO/FEFO.
  • OHSAS 18001/ISO 45001 (OH&S) and ISO 14001 (environmental).
  • working under strict regulatory requirements.
• Demonstrated ability to lead the development of EH&S policies and documents.
• Experience in conducting and/or hosting H&S inspections/audits.
• Experience with e-systems such as Enterprise Resource Planning (ERP),
• Warehouse Management Systems (WMS), Building Management Systems (BMS).
• Strong communication skills (comprehension, written, and oral). Experience in developing H&S and environmental policies and objectives, and being a voice for EH&S in the organization.
• Ability to multitask and direct multiple areas within the organization.
• Exceptional oral and written communication skills, with a dedication to health and safety.
• Flexibility to adapt easily to change in the workplace and changing priorities.
• Excellent computer skills (Microsoft Office Suite/Google Docs, e-systems).

Contract Duration: Full-time, ongoing.