GMP Operational Quality, Senior Specialist (v027)

  • Contract Duration: 6 months with potential to extend
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search


LenoxExecutive search is looking to fill a contractual role for a, GMP Operational Quality, Sr Specialist, with one of our global pharmaceutical clients. This is a contract position. Pharma experience is required. Batch record review is a MUST!

Key Responsibilities of a GMP Operational Quality, Sr Specialist:

  • Primarily responsible for providing quality oversight and support to manufacturing operations across all phases of development within the company or at contracted suppliers
  • Provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment and storage
  • Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
  • Responsible for approval of COAs, generating BSE/TSE statement and product labelling
  • Responsible for archival of batch records and other supporting documents
  • Provide QA support of change controls, GMP investigations and CAPAs.
  • Generates and/or revises Quality Agreements as needed
  • Responsible for generating performance metrics and trends of quality systems
  • Participate in inspection readiness and compliance audits and help support activities to drive the closure of any observations
  • Responsible for identifying risks and communicating gaps for GMP process/systems

optimization for area/equipment release, material disposition, quality systems etc.

  • Participate in continuous improvements of department processes
  • Act as a trusted advisor to program teams by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner

Minimum Qualifications of a GMP Operational Quality, Sr Specialist:

  • Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with 3-5 years of relevant work experience, or relevant comparable background.
  • Experience providing Quality support and oversight of GMP manufacturing operation including batch release
  • Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting
  • Knowledge of cGMP requirements governing oral drug products manufacturing practices
  • Flexibility to work beyond routine schedule if required per business needs (i.e. audit/inspection support)

Preferred Qualifications of a GMP Operational Quality, Sr Specialist:

  • Demonstrated success by independently leading cross-functional teams
  • Ability to independently lead cross-functional teams and represent the Quality unit
  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Ability to communicate effectively across all organizational levels
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Prior Experience in tablet formulation and/or continuous manufacturing
  • Experience successfully leading event investigations, Root Cause Analysis and CAPA
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