Quality Assurance Manager

2 weeks ago

Calgary, Canada Psygen Industries Inc. Full time

**PSYGEN LABS INC.**

Designation**:QA Manager (Maternity Leave Coverage)**

**Key Responsibilities**:

- Manage the overall site Quality Systems that encompass compliance to Regulatory GMPs and guidance governing manufacturing production, analytical testing, and all supporting functions and activities at the site.
- Manage, in collaboration with all stakeholders, the batch production readiness process. Anticipate and resolve issues to attain on time batch start deadlines.
- Participate in weekly meetings with Operations staff and provide weekly progress reports to facility management.
- Manage the Deviation program process that ensures thorough and timely investigations are completed to correctly identify root cause and develop and implement robust and comprehensive CAPA.
- Administer appropriate escalation of critical events to the Director of Quality and Compliance and ensure close communication with clients on quality issues potentially impacting product quality.
- Manage and oversee the batch record review and batch disposition process to ensure thoroughness and completeness of quality review whilst directing and coordinating the requirements and deliverables to achieve target batch disposition timings.
- Review and approve CAPA for deviations, OOSs, NCRs as required including CAPA Effectiveness Checks.
- Review and approve Validation and Qualification protocols and reports including analytical method transfers and validation.
- Oversee and manage change control program; review and provide input to change controls.
- Oversee supplier qualification program and vendor change notification process. Review and approve vendor and supplier audit reports where required.
- Review and approve SOPs for Quality Assurance, Quality Control, Manufacturing, and Facilities as required.
- Support client audits and oversee and approve client audit observation responses and audit close out reports.
- Co-chair Health Canada audits and collaborate with personnel to support all compliance requirements.
- Oversee preparation and approve annual product quality reviews prepared for client products.
- Develop, implement, and oversee Site Quality Risk Management Program including facilitation of training and education on Quality Management System and cGMP.
- Stay current with regulatory and industry standards and guidance and establish a process to communicate and educate site personnel.
- Would be responsible for implementation of e-QMS on site post closure of the validation batches for Psygen along with the entire QA team.
- Actively share knowledge and experience within the organization and provide input to corporate procedures and guidance on establishment and improvements in Psygen’s Quality Management System.

**Qualifications and Experience**:

- Bachelor’s degree in chemistry, pharmaceutical sciences, or related field.
- Minimum of 3 years’ experience as a Quality Manager or related progressive experience in a Quality leadership role.
- Demonstrated ability to lead the development of quality system processes and documents, including actively advocating for quality interests across departments.
- Effective communication skills, including comprehension, verbal, listening, and written.
- Strong analytical skills for assessing and improving complex processes.
- Proficiency in MS Office 365, Outlook, and Sharepoint.
- Knowledge of Quality Assurance related software including e-QMS, ELN, LIMS, ERP.
- Familiar with cGMP, FDA, and Health Canada Regulations, as well as USP and ICH guidelines.
- Understand the concepts and principles of Quality by Design to integrate quality requirements in a seamless fashion.
- Experience in conducting and/or hosting quality inspections/audits.
- Capacity to assess scientific and technological data from a quality perspective.
- Flexibility to adapt easily to change in the workplace and changing priorities.

**Salary**: $80,000.00-$100,000.00 per year

**Benefits**:

- Casual dress
- Dental care
- Extended health care
- Life insurance
- Paid time off
- Stock options
- Vision care
- Wellness program

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Calgary, AB T2A 7X1: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Quality management: 5 years (required)
- cGMP Manufacturing: 2 years (preferred)

Work Location: In person

  • Regional Quality Assurance Manager

    3 weeks ago

    Calgary, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing) Hybrid Travel 20-30% Calgary, AB The Company: Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This...

  • Regional Quality Assurance Manager

    3 weeks ago

    Calgary, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing) Hybrid Travel 20-30% Calgary, AB The Company: Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This...

  • Regional Quality Assurance Manager

    3 weeks ago

    Calgary, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing) Hybrid Travel 20-30%Calgary, ABThe Company:Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This role...

  • Regional Quality Assurance Manager

    3 weeks ago

    Calgary, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing) Hybrid Travel 20-30% Calgary, AB The Company: Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This...

  • Regional Quality Assurance Manager

    4 weeks ago

    Calgary, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing)HybridTravel 20-30%Calgary, ABThe Company:Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This role will...

  • Regional Quality Assurance Manager

    4 weeks ago

    Calgary, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing)HybridTravel 20-30%Calgary, ABThe Company:Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This role will...

  • Regional Quality Assurance Manager

    4 weeks ago

    Calgary, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing) Hybrid Travel 20-30% Calgary, AB The Company: Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This...

  • Regional Quality Assurance Manager

    4 weeks ago

    Calgary, AB, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing) Hybrid Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This role will support and champion all things...

  • Specialist, Quality Assurance

    3 weeks ago

    Calgary, Canada CB Canada Full time

    Specialist, Quality AssuranceOn behalf of our client, Procom is seeking a Specialist, Quality Assurance for a 6 month contract in Calgary, AB.Specialist, Quality Assurance Job DetailsThe Specialist, Quality Assurance will co-ordinate the day to day testing activities for multiple integration projects.Specialist, Quality Assurance Responsibilities The...

  • Quality Assurance Supervisor.

    1 week ago

    Calgary, Canada Coca-Cola Canada Full time

    About This Opportunity The Quality Assurance Supervisor is a fulltime position located at the Bottling Production Facility in Calgary. Reporting to the Quality Assurance Manager, the Quality Assurance Supervisor supervises and coordinates activities within the quality assurance department while working in close collaboration with the members of the...

  • Regional Quality Assurance Manager

    4 weeks ago

    Calgary, AB, Canada CPG Executive Search Inc. Full time

    Regional Quality Assurance Lead (Food Manufacturing) Hybrid Travel 20-30% Calgary, AB The Company: Our client is Canadian leader in Food Manufacturing. With multiple sites across Canada, they are currently going through an exciting transformation stage and adding a lot of technology, and investment projects across multiple sites in Western Canada. This...

  • Specialist, Process

    7 days ago

    Calgary, Canada H2 Safety Full time

    Celebrating our 20th anniversary in 2024, H2Safety Services Inc. is the largest Emergency Response Management provider in Canada. Equipped with decades of experience, our team of industry leading experts deliver comprehensive, tailored Emergency Management, Health, Safety, and Environment (HSE), Emergency Response Training, and Technology services to...

  • Quality Assurance Analyst

    3 weeks ago

    Calgary, Canada ARC Business Solutions Inc. Full time

    ARC Business Solutions Inc. is an established and customer oriented information technology solution provider with proven abilities to incorporate strategy, creativity and technical aspects into business solutions. Core business verticals are: Professional IT Services, Enterprise Content Management and Managed Services. ARC Business Solutions Inc. is...

  • Quality Assurance/Quality Control Supervisor

    2 days ago

    Calgary, Canada CMI GROUP INC Full time

    Position: Quality Assurance/Quality Control Supervisor (QA/QC Supervisor) Reporting to: Construction Manager Location: Alberta and Ontario Company: CMI GROUP INC.   About CMI GROUP Inc.: At CMI GROUP INC. we possess the expertise in the engineering, procurement & construction (EPC) of large s

  • Manager of Quality Assurance and Maintenance Training

    3 weeks ago

    Calgary, Canada CB Canada Full time

    Manager of Quality Assurance and Maintenance TrainingLocation: Calgary, ABPacific Western Transportation is currently seeking a Manager of Quality Assurance and Maintenance Training for a newly created role in Western Canada. Serving as a resource for our Student Line of Business, this role is responsible for supporting the maintenance activities of a...

  • SAP Quality Assurance

    3 days ago

    Calgary, Canada Canadian Pacific Full time

    **PURPOSE OF THE POSITION**: **POSITION ACCOUNTABILITIES**: - Manage and coordinate day to day SAP / custom software related testing activities at the project team level. Coordinate setup of test environments and test data management; - Evaluate business software and/or system requirements to ensure they can be translated into both functional and...

  • Quality Assurance/Quality Control Supervisor

    6 days ago

    Calgary, Canada CMI GROUP INC Full time

    Position: Quality Assurance/Quality Control Supervisor (QA/QC Supervisor) Reporting to: Construction Manager Location: Alberta and Ontario Company: CMI GROUP INC. About CMI GROUP Inc.: At CMI GROUP INC. we possess the expertise in the engineering, procurement & construction (EPC) of large scale solar (1-100MW). Our developments maintain the highest...

  • Quality Assurance/Quality Control Supervisor

    6 days ago

    Calgary, Canada CMI GROUP INC Full time

    Position: Quality Assurance/Quality Control Supervisor (QA/QC Supervisor) Reporting to: Construction Manager Location: Alberta and Ontario Company: CMI GROUP INC. About CMI GROUP Inc.: At CMI GROUP INC. we possess the expertise in the engineering, procurement & construction (EPC) of large scale solar (1-100MW). Our developments maintain the highest...

  • Quality Assurance/Quality Control Supervisor

    6 days ago

    Calgary, Canada CMI GROUP INC Full time

    Position: Quality Assurance/Quality Control Supervisor (QA/QC Supervisor) Reporting to: Construction Manager Location: Alberta and Ontario Company: CMI GROUP INC. About CMI GROUP Inc.: At CMI GROUP INC. we possess the expertise in the engineering, procurement & construction (EPC) of large scale solar (1-100MW). Our developments maintain the highest...

  • Quality Assurance/Quality Control Supervisor

    6 days ago

    Calgary, Canada CMI GROUP INC Full time

    Position:Quality Assurance/Quality Control Supervisor (QA/QC Supervisor) Reporting to:Construction Manager Location:Alberta and Ontario Company:CMI GROUP INC.About CMI GROUP Inc.: At CMI GROUP INC. we possess the expertise in the engineering, procurement & construction (EPC) of large scale solar (1-100MW). Our developments maintain the highest quality,...