Manager, R&D QA Liquid Dose

Job Summary

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 GMPcompliance needs of manufacturing, packaging and laboratory operations in Product Development.
• Interacts with Richmond Hill R&D) manufacturing/packaging groups, laboratories and Global R&D Project Management (GPM) 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,exicipients and packaging components) and non-commercial finished product batches (such as IMPs and registration/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, registration/submission and demonstration batches).
• Oversees the audit of data to release R&D raw materials (API,excipients and packaging components), IMPs and registration/submission batches.
• Review and approve Pharmaceutical Development Reports (PDRs), analytical method validation protocols and reports for R&D methods and other documents/reports required for regulatory applications/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
  • B.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
  • 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