Manager, R&D QA Liquid Dose

APOTEX; Richmond Hill; Hybrid; 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

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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

The Manager, R&D QA Liquid Dose is responsible for developing and maintaining a focused team, skilled and trained to support the compliance and business needs of R&D manufacturing, packaging and laboratory operations in support of New Product Development at Richmond Hill. Overall responsibilities include the disposition decisions made on R&D semi-finished and packaged materials, review and approval of experimental batch manufacturing documents, supervising and training staff, preparing and responding to audits, point of contact for local quality issues, ensuring investigation and deviations are handled in a compliant manner with pre-defined timelines, and working with the Associate Director, CMC QA to develop programs for ensuring the continuous improvement in the quality of operations in Product Development

Job 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.

Job Requirements

• Education
  • Sc. in Chemistry, Microbiology or related science
• Knowledge, Skills and Abilities
  • 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
• Experience
  • Minimum six (6) years of QA experience in the pharmaceutical industry, three (3) years of supervisory experience, preferably in a QA role

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

The hiring range for this position is $96,551 - $160,918 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.
The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.