Associate Director, Document Control and GxP Training Compliance

San Diego, CA 92121

Posted: 07/19/2021 Job Category: Pharma / Biotech Job Number: 2451

Job Description

Associate Director, Document Control and GxP Training Compliance

Industry: Pharmaceutical

Status: Full-Time Employee

Location: San Diego, CA

 

THE ROLE YOU WILL PLAY

 

  • Responsible for compiling data and generating metrics and reports for document control, records management, and training compliance.
  • In charge of designing curricula and delivering training and education to employees on processes and procedures used in the conduct of GxP activities.
  • Directly supervise personnel responsible for administration of the current electronic document management system.
  • Provide direction for development, implementation, and maintenance of the company’s document control system with a focus on the EDMS system (Veeva/LiveLink).
  • Support staff in addressing documentation discrepancies and apply required changes to documents.
  • Ensure appropriate maintenance of master files for quality system documentation.
  • Monitor and measure the effectiveness of GxP Training programs and publish and maintain the GxP Annual Training Schedule.

 

COMPANY PROFILE AND BENEFITS

 

  • Our client is passionate about developing novel drug therapies to improve people’s lives.
  • Many opportunities to learn and contribute to creative solutions, with the chance to grow.
  • Flexible time off policy including two company-wide shutdown periods each year.
  • You will be part of a reputable and stable company.
  • Exceptional compensation and benefits package.

 

BACKGROUND PROFILE

  • Bachelor’s with eight or more years of related experience in biotech/pharmaceutical GxP-regulated environment
  • Competency with EDMS/LMS systems maintenance and administration
  • Highly proficient with Microsoft products, including but not limited to, Excel and Microsoft 365.
  • Knowledgeable of applicable federal regulations, e.g., cGMPs, QSR, ISO, ICH, etc.
  • Experience with process change documentation/change management.
  • Expert knowledge of Quality Systems, QA Documentation processes, and Good Documentation Practices.

 

 

 

 

ABOUT ABA SEARCH

At ABA Search, we value professionalism, honesty, and hard work. We're positive, innovative thinkers, and we use creativity to turn challenges into opportunities. We thrive on deepening our expertise. We're energized by the life science and pharmaceutical industries, passionate about staffing, and committed to the success of our clients and candidates. That's what makes us "the name to know in recruitment."

Check out the 2020 Forbes list of Best Professional Recruiting Firms in America!  This was ABA’s 4th year in a row on this list and our 2nd year on the Best Executive Search Firms in America.

 

 

Meet Your Recruiter

Suzanne Stanford
Senior Recruiting Analyst

Suzanne joined ABA September 2020 as a Recruiting Analyst. She has a rich work history in healthcare, pharmaceutical sales, sourcing for biometrics and clinical trials, and public-sector human resources. She holds a Bachelor of Science Degree from the University of California, Davis. Suzanne upholds the client-centric business model that focuses on creating a positive experience for the client by providing exceptional service and building resilient business relationships. She firmly believes that it is not the number of calls you make in a day, rather, it is the quality of the conversation and effort put into each client/candidate to make their day easier. Suzanne gets great satisfaction sourcing for new candidates because she gets the opportunity to pair a person with a new position that will ultimately change their life and move their career forward.

A California native, Suzanne grew up in what would become Silicon Valley. She loved Santa Clara County and enjoyed the diversity of its people, the picturesque landscapes, and perfect weather. She gained valuable work experience in healthcare and pharmaceutical sales before she decided to stay home with her children. Ultimately, this choice would lead her family to move to Placer County where she then took on life as a “volunteer extraordinaire” for her local school district. She is now back in the workforce using her knowledge in healthcare and clinical data studies to pair candidates with their dream careers while assisting companies to find their ideal candidate.

Favorite Thing to do in Placer County: Hike, paddle board on Folsom Lake and enjoy the local wineries.

Favorite Quote: “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel.”  ~ Maya Angelou

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