Quality Systems Manager

Quality Assurance Santa Cruz, California


Description

Duties and Responsibilities

In this challenging and dynamic role, the Quality Systems Manager will be a part of the Quality Unit Organization and report to the Director of Quality and Regulatory Compliance.

The core mission of this role is:

  • Provide strategic oversight of the Document Control and training systems, ensuring appropriate processes, tools and resources to support business growth and innovation are in-place and operating efficiently and effectively
  • Manage document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as regulatory requirements, including: Master Manufacturing records, batch production records, raw material specifications, finished product specifications, SOPs, forms and work instructions
  • Manage training program, ensuring GMP personnel are appropriately and adequately trained to perform their assigned function to a high level of competence, regulatory compliance and efficiency
  • Establish and maintain the lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval, retention and destruction
  • Responsible for change notification to external customers and facilitating documentation changes to internal resources
  • Define resource requirements, plan and prioritize resources, and manage personnel to ensure optimal functional efficiency and delivery of high quality work to meet business requirements
  • Responsible for staffing and overseeing training, professional development of employees and conducting performance reviews within the team
  • Leads and identifies continuous improvement initiatives to meet company objectives
  • Contributes to the overall management of client specific documentation

Minimum Qualifications

  • Bachelor of Sciences or equivalent
  • 7+ years of relevant experience within the dietary supplement, food, or pharmaceuticals fields
  • Experience in Quality Assurance, process improvement or related function
  • Thorough knowledge of cGMP documentation requirements, and quality systems
  • 5 years of direct management experience
  • Advanced skills with MS Office applications and Adobe Acrobat
  • Preferred Qualifications
  • High ethical standards, being a role model of business compliance and integrity is required
  • Strong analytical, project management skills
  • Ability to work independently and to take responsibility for own projects and/or tasks
  • Results oriented with a hands-on, can-do attitude
  • Team player
  • Effective communicator-both written and verbal

Physical Requirements

While performing the duties of this job, the employee is regularly required to work in a stationary position, may move from one area to another, frequently operates a computer/office equipment, and frequently communicates with others. The employee may frequently lift and/or move up to 10 pounds and occasionally move and/or lift or move up to 25 pounds.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status.