Job Details

  • Title: Quality Contract Writer
  • Code: RCI-08807
  • Location:
  • Posted Date: 06/30/2020
  • Duration: 4 Months
Talk to our Recruiter

  Job Description

Description:

This is a remote /Work from Home role

Job Title: Quality Contract Writer

  • Primarily responsible for developing, negotiating and writing new and revised quality agreements and supporting agreements for R&D.
Responsibilities:
  • Effectively communicate audit results, both orally and in writing. Review corrective action plans / audit responses for adequacy and approve if adequate
  • Collect, analyze and report metrics pertaining to GxP Compliance
  • Manage Quality Agreement life cycle; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable
  • Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
  • R&D Quality Agreement liaison with Operations including negotiating / writing R&D elements for shared R&D / Operations Quality Agreements and associated documents
  • Manage processes for the timely QA writing / review / approval of Quality Agreement related policies, processes, procedures, templates and other documentation
  • Support audit activities with respect to Quality Agreements and other Quality System elements including audit preparation, responding to audit requests, subject matter expert resource
  • Review/edit GxP Service Provider business contracts/agreements and related documents for Quality related subject matter to ensure compliance with current regulations/guidances/industry standards and Quality System requirements.
Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.
  • 3-5 years’ Clinical Research Development / Manufacturing, finishing or analysis of investigation drug supplies
  • 8+ years’ experience in Quality Assurance or related field
  • Bachelor’s degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required
  • 5-7 years’ Experience in Quality Assurance / Regulatory Affairs (Pharmaceutical preferred)
  • Minimum of 7 years’ total combined experience required (Not necessarily the sum of the above)
Description Details

• Are you open to look at candidates willing to relocate? Can be virtual
• Years of experience/education and/or certifications required: BA/BS 8 + years
• What are the top 3-5 skills requirements should this person have?
1. Familiar with clinical supply chain
2. Familiar with GMP
3. Have good written communication skills
4. Demonstrated negotiation skills
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Quality agreements writer in pharma industry
• What type of environment is this person working in?
o Group setting
• Work Schedule (Define days,# of hours)? Normal work hours Mon-Fri, or flexible.
• Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Can work remotely
• Is the worker onshore or offshore? Onshore
• Will there be Domestic and/or International Travel? No