Senior Specialist, GMP Operational Quality (V957)

Website Lenox Executive Search

Job Description

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

Key Responsibilities:

  • 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

Minimum Qualifications:

  • 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)

Preferred Qualifications:

  • 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
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As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team