Website Lenox Executive Search
Lenox Executive Searching is seeking a Senior Specialist, GMP Operational Quality to fill a contractual role one of our Global Pharmaceutical Clients.
AREA: Quality Assurance
- Primarily responsible for providing quality oversight and support to manufacturing operations across all phases of development within Organization 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
- Responsible for raw material release, area clearance, line clearance and equipment release
- 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
- May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs
- Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 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)
- 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
- Fosters the demonstration of the Company Core Values and leadership behaviors