We are looking for a Quality Manager, working in the Pharmaceuticals & Medical Products industry in South San Francisco, California, United States.
Assists functions with identifying SOP needs related to Acertas SOP integration with AZ on GRAPSQA and Jubilee activities.
Assists with writing the SOP or reviewing the first draft of SOP before formal review.
Determines nominated reviewers from stakeholder departments for the review process.
Assists with the review process to ensure review timelines are on track and on time.
Assists with compiling edits and comments and leading the negotiations between departments on final edits.
Ensures that the final SOP meets formatting, grammar and Acerta vocabulary standards (department names are current and relevant, acronyms are defined and consistent, changes to previous SOPs are listed, tone is appropriate, level of detail is consistent, expectations for content is maintained).
Ensures that new SOPs do not contradict current procedures. Ensures that mandated procedures are in some way documented for confirmation.
Ensures that forms and templates that are referenced within the SOP are formatted correctly, function well and are also considered in the review process. They should also follow and document the required procedures in the SOP and not contradict the procedures.
The pay we are offering is 64 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Minimum of 6 years in pharmaceutical industry, specifically in biopharma companies or CROs
SOP development and management experience is required
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.