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Sr. Manager R&D QRM

San Diego, CA 92130

Posted: 02/07/2024 Employment Type: Contract Industry: Research and Discovery Job Number: 11575 Pay Rate: $75.00 - $85.00

Job Description

Our client develops and commercializes therapies for hallucinations and delusions associated with Parkinson’s disease.


Descriptions:
  • Responsible for managing assigned Research and Development (R&D) Quality Risk Management activities, including assessment and quality control of the Company's clinical trials' execution in a Good Clinical Practices (GCP) regulated environment.
  • Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP).
  • Candidate will be required to work closely with internal R&D teams and Contract Service Providers (CSPs) as clinical trials are designed and conducted.
  • Will be required to identify emerging issues and compliance risks, measure performance metrics, and suggest opportunities for improvement for clinical trial related processes and procedures and contribute to (or lead efforts to) their implementation.
  • Potential to coach and support junior associates in R&D Quality Risk Management (R&D QRM) department, where needed.

Must possess:
  • Experience with drug development process, including affinity with clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management.
  • Strong knowledge of GCP, including affinity with quality management and performance metrics and experience with Root Cause Analysis and CAPA development.
  • Experience with multiple IT programs and systems, including but not limited to Clinical Trial Management systems, eTMF, eCRFs, Microsoft Office (including above average Excel skills), quality workflow systems.
  • Knowledge of Good Laboratory Practices, PV, FDA and/or EMA/MHRA regulations.
  • Excellent communication skills, both verbal and written. Able to work independently as well as in cross-functional teams.
  • Excellent pro-active, interpersonal, problem-solving, conflict resolving skills.
  • Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.
  • Ability to establish and maintain frequent internal and external relationships with Development, Regulatory Affairs, Pharmacovigilance & Legal departments, regulatory agencies, CROs, clinical investigators, etc.
  • Ability to interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance issues and the pro-active management of GCP and PV quality risks – under supervision if needed.
  • Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions.
  • Skilled at working effectively with business partners and management, and appropriately signal and escalate matters of significance to the organization.
  • Ability to travel up to 10% of the time.

Job Requirements

Requirements:
  • Bachelor’s or Master's degree in a relevant field (e.g. biology, nursing, neuroscience, psychology, biochemistry, clinical pharmacology, or related).
  • An equivalent combination of relevant education and applicable job experience may be considered.
  • Minimum of 6 years R&D focused pharmaceutical/Health Care experience in a GCP regulated environment including some experience in R&D Quality Risk Management or R&D Quality Assurance systems and Health Authority regulations.
  • Experience in a matrix team environment and involvement and contribution to continuous improvement projects.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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