Return to Careers

Manager, Quality Operations

Reporting to the Director, Quality Operations, the Manager of Quality Assurance (QA) leads and develops our QAIP, Compliance, and Microbiology teams. You oversee all activities associated with API, raw material, semi and finished product releases, and the review of all related documentation to ensure conformance to GMPs, requirements and regulations. You will ensure Pillar5 maintains the highest standards internally and externally, upholding global Quality requirements. You will liaise with internal and external stakeholders to ensure compliance with current QA requirements. The incumbent also ensures that all products released from the site are manufactured to and meet customer and regulatory specifications.

Responsibilities

    • Ownership of QAIP team – develop, implement, and monitor processes and procedures to ensure proper in-process testing of solid dose and aseptic product lines
    • Manage Microbiology team –
    • Develop and implement quality standards to input, release, distribute, calibrate and maintain controls related to pharmaceutical products in compliance with Health Canada regulatory requirements and guidelines.
    • Manage and assist with the investigation of deviations and documentation of deviations and corrective actions/preventive actions (CAPAs)
    • Manages review and approval of GMP documents related to Quality Systems such as but not limited to Master Batch Records, SOPs, validation documents, stability reports, product specifications, APQRs, etc.
    • Provides Quality Assurance presence on the production floor to ensure quality oversight of production activities and ensures those activities and relevant documentation are maintained in compliance with all applicable regulatory standards and guidelines.
    • Provide professional leadership, ensure growth opportunities, and development planning for entire QA team with the goal of building a pipeline of sustainable talent.
    • Manage the Compliance Self Inspection (CSI) and the site GMP training activities
    • Develop QA operating plan (capacity planning), monitor performance, analyze variances to support the S&OP Supply Process and Site On Time Delivery targets

Qualifications

    • Bachelor of Science degree or equivalent
    • 5 to 7 years supervisory/management experience, ideally in a Quality Assurance role in a pharmaceutical manufacturing environment
    • In-depth knowledge of GMP guidelines, quality systems and current HPFBI GMP related policies and directives as well as demonstrated experience in quality investigations
    • Proven planning, organizational, and time management skills
    • Excellent communication and interpersonal skills
    • Training or experience in operational excellence programs such as Six Sigma or LEAN an asset
    • Proficiency in computer applications, specifically Microsoft Office

Application Process

Application process: Please send your resume using the form below.

  • Drop files here or
    Max. file size: 300 MB, Max. files: 3.

    Call Now
    Email Us