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Research Quality Assurance (RQA) Consultant

Cambridge, MA

Posted: 06/18/2019 Employment Type: Contract Job Category: Clinical: Quality Job Number: 2373

Our client is looking to add a Research Quality Assurance (RQA) Consultant to their team for a term of 6 months. Reporting to the Head of Quality, the RQA Consultant will be responsible for development, implementation and oversight of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP) quality systems. This is a hands-on consulting role centered on leading a risk-based audit program supporting clinical and post approval development activities.

The position requires an expert knowledge of GCP and a good working knowledge of GLP and GVP. This person will act as a subject matter expert within the department and for clients group within company, as well as providing compliance oversight to external CROs. This person must be capable of formally/informally influencing, leading, and guiding both internal departments and external vendors through collaborative relationship building.

Responsibilities:
  • Ensures a robust and risk based audit program is successfully realized by leading/conducting both internal and external audits related to GCP/GVP/GLP.
  • Establish and maintain processes and tools for the preparation, conduct, reporting and follow-up of GCP/GVP/GLP audits.
  • Collaborates with internal and external stakeholders and partners to enable and ensure appropriate implementation of the US and EU compliance requirements and associated industry guidelines as applicable to GCP/GVP/GLP.
  • Provide senior management with in-depth analysis and risk management reports for compliance and quality related matters and recommend solutions.
  • Ensure FDA inspection-readiness and serve as Quality Liaison for regulatory inspections and partner’ s audits; provide post-inspection/audit support and follow up as required.
  • Assist in the preparation and review of regulatory submissions for FDA and global health authorities
  • Maintain high level of awareness, expertise in international GCP/GVP/GLP regulations and provide input into the development of quality standards and procedures in related system and processes.
  • Manage contracts and day to day activities of external contractors as needed.
  • Develop and conduct training on current regulations and compliance issues.
  • Represent QA at project teams and discussions for GCP/GVP/GLP related issues.
  • Participate in team efforts to achieve departmental and company goals.
  • Work with Program Management, Clinical Operations and Drug Safety and Pharmacovigilance to build Quality related activities into timelines.
  • Assure that the appropriate suites of Standard Operating Procedures (SOPs) are in place and optimally maintained to support the above activities.

Requirements / Qualifications:
  • BS or equivalent in a scientific discipline and 12+ years of relevant experience or an advanced degree and 10+ years of relevant experience within the pharmaceutical industry including a leadership role in Quality.
  • Extensive knowledge of pharmaceutical/biotech industry centered on FDA, EU, ICH, GCP/GVP.
  • GCP is required, It can be a combination of GCP and GVP, but it is a MUST
  • Superb organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training and to present information in an advisory capacity.
  • Familiarity with PV reporting, Inspection readiness, Clinical program quality oversight, Clinical site audits, clinical vendor audits, Regulator Submission review and audit, and Clinical Study Report audit
  • Attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
  • Able to travel (some international) up to 25%.
  • Ability to work both independently and collaboratively with project teams and cross functionally, to build productive relationships with internal and external partners, to influence decision making and to engage in conflict resolution.

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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