Kelly® Science & Clinical is seeking a Quality Assurance Manager for a Direct Hire opportunity at an innovative and growing pharmaceutical manufacturing client in Sacramento, CA.  If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at empowering Experts.

Salary: $85-95K

Schedule: M-F Dayshift with the ability to support 24/7 manufacturing issues as needed on call for nights and weekends.

Overview 
Our client is a pharmaceutical company looking to grow their Quality Team and is looking to add people dedicated to their mission of upholding highest standards of integrity and excellence.
 
In this role you’ll be responsible for overseeing all Quality Assurance Activities related to the manufacturing of pharmaceutical products.  This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (e.g., FDA, EMA, MHRA).  The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement.

Responsibilities:

• Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness.
  

• Provide triage support across departments to address quality issues, ensuring timely escalation to management when necessary.
  

• Review and approve deviations, including the associated investigation reports, and corrective/preventative actions.
  

• Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations.
  

• Review and approve sampling protocols, risk assessments, and master batch records.
  

• Author, review and approve SOPs as appropriate for both Operations and Quality.
  

• Assist with additional tasks, such as Master Data management / approval, GMP area walkthroughs, product changeover activities.
  

• Participate in internal audits, support regulatory inspections or customer audit activities, as needed.
  

• Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance.
  

• Assist in the development or assignment of training to key stakeholders related to QMS.
  

• Contribute to the preparation of Periodic Quality Reviews.
  

• Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Quality standards.
  

• Support the implementation of a quality culture and best practices within the affiliate organization

Qualifications:

• Candidates with a Bachelor’s degree must have at least 10 years of relevant experience; those with a Master’s degree require 5+ years of experience.
  

• Strong background in manufacturing and quality assurance within the pharmaceutical or biotechnology industry is essential.
  

• Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
  

• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
  

• Experience in quality administered systems.
  

• Experience with regulatory compliance and documentation.
  

• Ability to mentor and review the work of other colleagues.
  

• Knowledge of electronic systems such as Compliance wire., Veeva, Track wise, SAP, LIMS, Maximo, and Master Control.
  

• Collaboration skills and the ability to independently engage with a wide range of colleagues, and management to gather the input and background knowledge needed to complete assignments.
  

• Must be able to gown for entering controlled areas
  

• Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.).
   

Additional Benefits:

• Annual bonus Eligibility (Based on yearly company and personal performance)
  

• Medical, dental and vision coverage
  

• Paid time off plan
  

• 401k savings plan with No matching

What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
 

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