GMP Operational Quality Senior Specialist (v496)

  • Contract Duration: 6+ months, possibility to extend, Hybrid Remote
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking for a GMP Operational Quality Senior Specialist for a contractual role with one of our global pharmaceutical clients. Pharmaceutical manufacturing quality assurance experience is a MUST!!!

General Summary of a GMP Operational Quality Senior Specialist:

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives.

Key Duties and Responsibilities of a GMP Operational Quality Senior Specialist:

  • Supports authoring of Annual product reviews ensuring appropriate CAPA actions are identified.
  • Assists with preparation of Quality Management Review materials
  • Supports regulatory surveillance activities
  • Identifies and facilitates continuous improvement efforts
  • Helps represent Company Quality on cross-functional working teams, applying strong communication and collaboration skills.
  • Support continuous improvement projects
  • Annual Product Review
  • Trending product quality events, trends of analytical events

Knowledge and Skills of a GMP Operational Quality Senior Specialist:

  • Experience supporting multiple projects/teams within stated objectives and timelines
  • Experience supporting cross-functional team members and collaborating effectively
  • Good communication skills (written and verbal) and the ability to exchange potentially complex information
  • Able to integrate activities with other groups, departments and project teams as needed
  • Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
  • Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
  • Expanded conceptual knowledge of cGMP’s in a pharmaceutical setting
  • Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
  • Technical Writing

Education and Experience of a GMP Operational Quality Senior Specialist:

  • Bachelor’s degree in scientific or allied health field (or equivalent degree)
  • 5-7 years of experience, or the equivalent combination of education and experience
Upload your resume here.

Our COVID-19 Policy

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