Senior Manager Quality Assurance

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Senior Manager Quality Assurance manages the QA Team responsible for quality oversight of analytical Quality Control. This oversight encompasses: release and stability testing of Raw Materials, Cell Banks, Bulk Drug Substance, and Drug Product. The incumbent must apply sound scientific principles to meet quality and business goals and possess the acuity and authority to serve as the delegate for the Head of GMP Quality Assurance.  

How you’ll spend your day

Serve as delegate/secondary to the Head of GMP Quality Assurance during high level project planning meetings and serve as the Quality Assurance Authority for the following:

• Critical Quality Attribute Committee: Critical Quality Attributes (CQAs) include “physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality”. The CQA committee will participate in the identification and risk assessment of quality attributes, taking into account the target product profile, molecular design, process understanding, risk management and control strategies for the CMC biologics portfolio products at three stages from pre-clinical development to license application.   The CQA committee is a cross-functional team with stakeholders from various groups within CMC.
• Product Specification Oversight Committee: responsible for critically evaluating and endorsing the proposals for new and when applicable, revised product Specifications as presented by the Analytical Development group and providing recommendations and/or endorsement of the decisions requested.
• Raw Material Specification Oversight Committee: A group with members from Analytical Development, Process Development, Drug Product Development and Operations, Quality Control, Material Sciences, Quality Assurance, and Manufacturing (Planning and Operations) who is consulted on any specification initiations, changes, or retirements to ensure appropriate testing of controlled materials.
• Stability Review Committee: the responsibilities of this Committee include 
  • Review and endorse stability study designs and batch selection
  • Review stability trend evaluation findings
  • Review and endorse stability shelf-life assignments
  • Review and endorse product temperature excursion matrices
• Decision-making Authority (go/no go) for Quality Control GMP activities including: 
  • Quality evaluation of Product Stability Program
  • Quality evaluation and approval of Product Specification creation/revision
  • Raw Material Specification creation/revision
  • Analytical QC Release Data of Product and Raw Materials
  • Pre/Post Approvals - Analytical Development Method Qualification
  • Pre/Post Approvals - Analytical QC Method Validation
• Direct management of a team of Quality Assurance Analysts
• Ensure activities are performed/completed using current Good Manufacturing Practices.
• Review of analytical testing data for accuracy/completeness/cGMP documentation.
• Serve as a subject area Quality Assurance SME, representing QA on multi-functional teams in support of assignments and investigations.
• Provide feed-back/communication of any issues.
• Review and approve analytical method validation protocols, method transfer protocols, stability protocols, and technical reports.    
• Review and approve SOPs, work instructions, and controlled forms.
• Utilize Quality Metrics Systems to review and approve change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks.

Additional Responsibilities, as needed / Preferred Experience

• Corporate Standard Gap Assessments for Quality Control related procedures.
• Support regulatory agency filings, inspections, and internal audits.
• Review of production records ensuring quality and proper cGMP documentation. 
• Perform Raw Material and Product disposition and release.  

Your experience and qualifications

• BS/BA in life sciences required; MS/PhD in life scienc