Quality Systems Manager

Posted 05 Dec 2022

Carlsbad, California - United States

Req Id 258934

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 


 

Your Role:

 

The Quality Systems Manager (Quality Manager) reports directly to the Sr. Manager, Quality Systems, and is responsible for the oversight and management of quality systems at the SAFC Carlsbad site. The Quality Manager is the primary quality contact for systems at the site supporting the contract manufacturing business. This includes, but is not limited to developing and driving appropriate performance KPIs, managing timelines and working with various stakeholders to successfully deliver both internal and customer deliverables while maintaining site quality systems in a state of compliance and inspection readiness.

 

This role requires the Quality Manager to independently manage individual and group timelines, as well as effectively communicate with staff, team members, cross-functional stakeholders, clients, suppliers, and external regulatory representatives. The Quality Manager effectively leads, initiates and drives change for the site to develop best-in-class support within the Quality organization. Additional responsibilities of this role may include:

 

  • Management of the supplier program and serve as the primary point of contact for the program
  • Oversee/support the Internal Audit program including conducting self-inspections (internal audits)
  • Support the creation, review, approval, execution, extension, and/or closure of site Deviations (Events), CAPAs, and Change Controls
  • Complete, review, and/or approve site Risk Assessments
  • Hold/Support Change Management/Control Review Board meetings
  • Work with and support other organizations on client communications in relation to changes as needed
  • Act as site SME on quality systems and conduct site training as needed
  • Chair/Support CAPA Review Board Meetings
  • Measure/Monitor Quality Systems data and submit monthly metrics to Quality Management
  • Gather data for client Annual Product Reviews as needed
  • Support Client Audits and Regulatory Inspections as required

 

Who you are:

Minimum Qualifications:

  • Bachelor’s Degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science field
  • 6+ years of experience working within Quality in a cGMP environment
  • 2+ years of experience working in Contract Manufactured Organization (CMO)

 

Preferred Qualifications:

  • Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
  • Ability to coordinate Quality System records and drive to completion
  • Experience supporting client audits and regulatory inspections
  • Organized and detailed oriented with strong and effective written and verbal skills
  • Strong interpersonal communication skills
  • Strong people management skills
  • Ability to work independently within prescribed guidelines and collaboratively as part of a team
  • Proven ability to take direction and commit to ensuring objectives are completed by due dates.
  • CAPA Program Management experience
  • Ability to work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities

 

Pay Range for this Position- $49,500 - $148,900

Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data.  Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

Apply Now