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Senior Manager, Pharmaceutical Technology

2 months ago

Toronto, Ontario, Canada Sun Pharmaceutical Industries, Inc. Full time

Position Overview:

The Senior Manager of Pharmaceutical Technology is responsible for overseeing the capabilities of the Pharmaceutical Technology division to guarantee successful product launches, technical transitions, scale-up processes, and operational effectiveness.

Key Responsibilities:

  • Direct resources within the Pharmaceutical Technology team to ensure timely launches across all markets, operational support, product transitions, and scale-up initiatives.
  • Oversee all product launch activities, coordinating with cross-functional teams including Quality Assurance, Quality Control, Engineering, Materials Management, Procurement, and Operations.
  • Collaborate closely with the Validation team to ensure successful launches, product transitions, and scale-ups.
  • Provide expertise to the Quality Assurance Investigations Team regarding process and material-related inquiries.
  • Assist Material Management and Vendor Management teams with expertise in raw material and vendor approvals.
  • Lead initiatives aimed at enhancing manufacturing processes within Operations.
  • Manage the development and maintenance of Master Formulas.
  • Support Quality Control method development by supplying both small-scale and full-scale batches.
  • Work alongside Regulatory Affairs to address FDA inquiries, Health Canada clarifications, and deficiency letters.
  • Conduct or facilitate quality investigations as necessary.
  • Ensure all Good Manufacturing Practice (GMP) documentation is completed accurately and promptly.
  • Complete all required training and maintain personal training records.
  • Participate in and/or lead Non-Conformance Investigations.
  • Execute Corrective and Preventive Actions (CAPAs).
  • Initiate and manage actions necessary to close Change Controls.
  • Engage in Internal, Customer, and Regulatory Audits.
  • Develop and revise Standard Operating Procedures (SOPs) as needed.
  • Identify training and compliance gaps within the team.
  • Educate Quality Control analysts, compounders, filling personnel, and pharmaceutical staff on best practices for testing, sampling, and investigations.
  • Perform additional duties as assigned.

Required Knowledge, Skills, and Abilities:

  • In-depth understanding of pharmaceutical operations.
  • Proficient knowledge of test method validation and transfer processes.
  • Advanced familiarity with GMP, GLP, FDA, and HPFBI regulations.
  • Strong organizational skills with the ability to manage multiple tasks effectively.
  • Comprehensive knowledge of continuous improvement methodologies.
  • Exceptional written and verbal communication skills.
  • Strong interpersonal abilities.
  • Proficient in relevant software applications such as Trackwise and MS Office Suite.

Qualifications:

  • A minimum of a Bachelor’s degree in Chemistry or a related field.
  • At least 5 years of experience in Research & Development, Quality Assurance, Quality Control, or Manufacturing within the pharmaceutical industry, including a minimum of 5 years in a supervisory or leadership capacity.
  • Demonstrated success in managing quality investigations.

Problem-Solving Capabilities:

  • Responsible for making complex decisions regarding launch priorities, equipment availability, and batch scheduling to ensure successful Day 1 launches.
  • Address challenges associated with collaboration across various departments and functions within the organization.

Working Environment:

  • Generally pleasant working conditions with some exposure to operational environments that may include elevated noise levels and minimal exposure to chemicals used in testing and sampling.

We appreciate all applicants; however, only those selected for further consideration will be contacted. This position is open to individuals legally authorized to work in Canada.

Sun Pharmaceutical Industries, Inc. values diversity in the workplace and is committed to achieving employment equity. We aim to attract, develop, and retain talented employees from diverse backgrounds, benefiting from a wide range of experiences and perspectives. Our recruitment practices support this commitment and comply with all applicable laws.

In accordance with the Accessibility for Ontarians with Disabilities Act, we will provide accommodations throughout the recruitment and selection process to applicants with disabilities. If selected to participate, please inform Human Resources of any accommodations required.

NOTE: Employment is contingent upon the successful completion of a background check, which may include educational, employment, reference, and criminal record checks.

AGENCY NOTICE: Sun Pharmaceutical Industries, Inc. does not accept unsolicited resumes from recruiters or employment agencies. Without a signed Services Agreement, we will not consider any referrals or agree to payment of referral or recruitment fees.