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Senior Quality Systems Associate

Department: Quality Assurance

Job Title: Senior Quality Systems Associate

Reports To: Quality Systems Manager

Description:

The Senior Quality Systems Associate serves an integral role within the global Avid Quality Assurance (QA) function in support of the routine measurement of quality performance indicators, emerging or changing regulations, and managing key quality systems. This role supports activities to ensure internal compliance by managing the Avid internal audit program and assists Management in working with Eli Lilly QA to maintain alignment to corporate policies.

In collaboration with Avid’s contract manufacturers, the Senior Quality Systems Associate leads and manages quality agreements and is responsible for generating reports for the Annual Product Reviews. The Senior Quality Systems Associate supports activities associated with critical events and investigations. As required, this position also supports the Supplier Quality Management program by participating in audits of suppliers, service providers and contract manufacturers.

Responsibilities:

  • Review and approve internal investigations (deviations, OOS);lead or manage open investigation and consult for internal GMP functions
  • Provide support and consult for CAPA development
  • Maintain key QMS tracking systems and performance metrics
  • Manage Avid internal audit program including setup schedule and ensure audit performed according to scheduled.
  • Manage change control system
  • Manage GMP training program
  • Develop and manage continuous improvement program including CAPA, quality plan
  • Collaborate with EU QA and CMC personnel on systems related data
  • Support GMP regulatory intelligence monitoring, driving feedback, risk analysis, and reporting
  • Support data management and reporting for the Avid quarterly management review
  • Plan and lead corporate audit /regulatory Inspection

Requirements:

Basic Qualifications:

  • Bachelor’s degree in Pharmacy or other discipline relevant to drug discovery, development, or commercial products
  • Minimum 7 years of Quality Systems/Assurance experience in a regulated environment such as GMP or ISO
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences:

  • Knowledge or experience in aseptic processing environments and analytical testing, e.g. HPLC, GC, residual solvents, impurities, sterility and endotoxin testing. Parenteral therapeutic drug development experience is strongly preferred
  • Strong knowledge of relevant regulations of US and European drug GMPs, ISO a plus
  • Knowledgeable in Quality Management Systems (FDA or ICH approach to risk management and QMS)
  • Working knowledge of third party manufacturing and contracts preferred
  • Experience in compilation and review of Annual Product Reviews (APRs)
  • Demonstrated ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints
  • Ability to audit GxP processes and Quality Management Systems
  • Experience with review of CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit reports
  • Experience in regulatory inspections
  • Ability to assess Quality System related procedures for their effectiveness and make improvements, as necessary
  • Proficient in Microsoft Office Suite, especially MS Excel (with formula and macro functionality) strongly preferred
  • Experience with electronic quality systems such as EDMS or Regulus, TrackWise, SuccessFactor or ComplianceWire
  • Strong verbal and written communication skills
  • Ability to work independently and escalate issues (notification to management), when necessary
  • Meeting facilitation and project management skills
  • Ability to simplify complex processes/problems and propose alternate solutions
  • Ability to identify and manage risks to project timelines
  • Multi-lingual preferred

Additional Information:

  • Ability to travel in US and international up to 5-10%
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status


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