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Senior QA Project Manager (cGMP – Pharmaceutical – Inspection Readiness) JD820647

JD820647

DPS is seeking a knowledgeable Quality professional to work with a pharmaceutical client in the Boston, MA area. This individual would be expected to take over the development of an FDA inspection readiness program and help the client to improve their current SOPs and systems to build a more robust inspection readiness plan and procedure. The ideal candidate would own this scope of work and lead the way to implement facility improvements, SOPs and plans with the ability to offer suggestions to the client on industry best practices and policies.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
01/03/2020
Days Remaining:
6
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior QA Project Manager (cGMP – Pharmaceutical – Inspection Readiness)           JD820647

Boston, MA area

 

DPS is seeking a knowledgeable Quality professional to work with a pharmaceutical client in the Boston, MA area.  This individual would be expected to take over the development of an FDA inspection readiness program and help the client to improve their current SOPs and systems to build a more robust inspection readiness plan and procedure. The ideal candidate would own this scope of work and lead the way to implement facility improvements, SOPs and plans with the ability to offer suggestions to the client on industry best practices and policies.

 

Responsibilities:

  • Champion the maintenance and continual improvement of compliance audit and inspection readiness systems.
  • Lead and participate in GMP/GLP/GCP audits and Inspection Readiness Site visits.
  • Participate in cross functional teams to identify and champion GMP/GCP inspection readiness activities to defend business processes.
  • Pro-actively identify gaps in corporate practices, policies and procedures and prioritiz911833.421173e based on current regulatory environment, guidelines and regulations. Support efforts to remediate or defend identified inspection risks. Present updates to Senior Management.
  • Lead partnerships with key stakeholders to deliver solutions and training that facilitate maintenance of ongoing state of inspection readiness.
  • Evaluate the GxP compliance status of the company in relationship to industry and Regulatory Agency expectations and assesses the effectiveness of established programs, systems and processes.
  • Participate in the authoring and review of department policies and procedures.
  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

 

Qualifications & Experience:

  • Bachelor’s Degree in science or related technical field.
  • 5+ years’ of experience in pharmaceutical or biotech industry.
  • Experience with GCP/GLP/GMP auditing practices as well as regulatory authority inspections, including both FDA and EMA inspections.
  • Effectively collaborate with external 3rd parties to execute the company s Compliance and inspection readiness strategy and approach.
  • Familiar with all phases of biologic and/or small molecule drug development.
  • Flexibility in problem solving, providing direction and work hours to meet business objectives.
  • Ability to interpret and relate Quality standards for implementation and review.
  • Ability to communicate clearly and professionally both in writing and verbally.
  • Strong organiz911833.421173ational and project management skills with a track record of meeting goals/objectives.
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