R&D QA Manager, Liquid Dose — Lead GMP Excellence

APOTEX; Richmond Hill; On-site; CAD 97,000 - 161,000; Full time

Benefits offered by this job

Disability accommodation

Job summary

Apotex is a Canadian-based global health company seeking a Manager, R&D QA Liquid Dose to lead a focused team in GMP-compliant product development at Richmond Hill.

The role includes review of batch records, change controls, CAPA, regulatory submissions, and audits; develop processes for 21 CFR Part 4; mentor staff and ensure timely investigations. Strong leadership, collaboration, and documentation skills are essential to drive quality and compliance.

Qualifications

• Thorough understanding of GMP requirements and their application in a manufacturing and packaging environment within R&D for pharmaceutical liquid dosage forms.
• Strong understanding of regulatory requirements for IMPs and registration batches.
• Excellent interpersonal skills with recognized leadership ability.
• Demonstrated ability to handle multiple work assignments.
• Experience with technical report writing / scientific documentation

Responsibilities

• Manages the on-going QA activities which support the business and GMP compliance needs of manufacturing, packaging and laboratory operations in Product Development.
• Interacts with Richmond Hill R&D manufacturing/packaging groups, laboratories and R&D Project Management to determine scheduled activities and changes to the manufacturing schedule.
• Oversees assignment of work to direct reports for the review and approval of R&D manufacturing/packaging masters and executed manufacturing/packaging batch documents, as well as the review and approval of R&D specifications, test results, release of experimental raw materials (API, excipients and packaging components) and non-commercial finished product batches (such as IMPs and submission batches).
• Provides leadership and operational oversight for establishment of records and processes in support of 21 CFR Part 4 requirements for Combination Products.
• Reviews and approves Master Manufacturing/Packaging Masters and executed batch records for non-commercial materials (such as IMPs and submission batches).
• Review and approve documents required for regulatory submissions.
• Review, coordinate and approve activities for deviation investigations and CAPA for experimental materials and manufacturing of non-commercial batches. These include the complaint investigations for IMPs.
• Supports change through review and approval of change control requests for master manufacturing/packaging documents, analytical methods, specification, SAP material code creations, SAP Master Data, Standard Operating Procedures (SOPs) and other controlled documents.
• Ensure implementation of appropriate processes and continuous improvement initiatives in order to maintain effective quality standards in R&D.
• Provides assistance and leadership in preparation activities leading up to, during, and following regulatory or customer inspections.
• Provides support and management of the R&D self inspection program at Richmond Hill.
• Serve as primary contact and consultant for quality issues pertaining to R&D operations.
• In conjunction with the Associate Director, CMC QA, conducts appropriate resource planning analysis for headcount forecast.
• Participate and lead performance conversations with employees, check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of direct reports with all compliance programs and company policies and procedures.
• All other duties as assigned.

Skills

GMP knowledge

Leadership

Regulatory knowledge

Technical report writing

Interpersonal skills

Education

BSc in Chemistry/Microbiology

Job description

Apotex is a Canadian-based global health company seeking a Manager, R&D QA Liquid Dose to lead a focused team in GMP-compliant product development at Richmond Hill.

The role includes review of batch records, change controls, CAPA, regulatory submissions, and audits; develop processes for 21 CFR Part 4; mentor staff and ensure timely investigations. Strong leadership, collaboration, and documentation skills are essential to drive quality and compliance.