Senior Manager, Quality Systems Compliance

  • Townsend St, San Francisco, CA, USA
  • Full-time

Job Description

The Sr. Manager, Quality Systems Compliance is responsible for implementing the Quality System; and routinely assessing and monitoring its effectiveness.  This person will ensure the organization’s compliance with required U.S. and international medical device quality standards and regulations.  He/she will participate in, and support successful completion of regulatory audits and assessments.  Direct activities include supporting Design Controls activities, Internal Audits, Supplier Audits, Management Reviews, FDA/ISO/State of California inspections, CAPA Management, and Complaint Handling Management.

Responsibilities:

  • Providing support to the Sr. Manager, Quality Assurance – Design Controls on Design Control activities.
  • Interpretation of FDA, ISO and other pertinent requirements for creation and implementation of Quality Management System improvements and updates.
  • Chair the Audit Board and follows up to ensure timely closure of audit corrective actions.
  • Provide guidance to the QA staff responsible for administering and processing document change orders.
  • Provide guidance and support on matters of FDA / ISO regulations to cross-functional departments and staff
  • Integrate regulatory, compliance, quality issues into audit and assessment planning process, based on risk.
  • Ensure compliance to Regulatory, Division, Site and Corporate policies and procedures by promptly reporting non-compliance issues.
  • Maintain records of Executive Quality System Management Review meetings.
  • Direct the Corrective Action Preventive Action (CAPA) program and ensure CAPAs are being resolved effectively.
  • Manage Complaint Handling Management System.
  • Control the QA Release program (acceptance criteria for product release).
  • Identify compliance risks against current standards and/regulations that may result in providing guidance in the planning and execution of Quality System improvements.
  • Maintain and demonstrate understanding of global standards and regulations.
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Managing and executing Internal Audits.
  • Provide tracking, trending and reporting on key audit and regulatory program metrics and issue quarterly dashboard for management review.
  • Conducting Supplier Audits and overseeing Supplier Management.
  • Managing Ancestry QMS Training requirements.
  • Performing other duties as assigned or required.

Qualifications

Education:

  • Bachelor degree or equivalent in a technical area.  Bachelor’s degree is highly preferred.

Background & Experience:

  • Minimum eight (8) years of experience in the Medical Device / Bio Tech / related industry.
  • Three (3) years minimum required in Quality Compliance Management
  • Qualified Lead Auditor a plus
  • Member of RAPs a plus
  • Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, CFR 809 (IVDD), ISO 13485, etc.
  • ASQ (American Society for Quality) certifications a plus
  • Understanding of MasterControl

Additional Information

Ancestry is a profitable, growing company with a positive, high-energy environment. Together, our dedicated teams are harnessing the power of technology and using it to simplify the way people connect with their families and their unique legacies. Our work environment is fast-paced and challenging, but also extremely exciting. You’ll work with a team of passionate, engaged individuals. We offer excellent benefits and a competitive compensation package. For additional information, regarding our benefits and career information, please visit our website at http://ancestry.com/careers

Ancestry is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at Ancestry via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Ancestry. No fee will be paid in the event the candidate is hired by Ancestry as a result of the referral or through other means.

Ancestry is an Equal Opportunity Employer that makes employment decisions without regard to race, color, religious creed (including religious dress and grooming practices), national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and medical conditions related thereto), sexual orientation, gender, gender identity and expression, age (40 and older), mental or physical disability (including HIV and AIDS), medical condition (cancer and genetic characteristics), veteran status, citizenship, marital status, genetic information, or any other basis that is prohibited by applicable law.   The Company also makes reasonable accommodations to applicants or employees with qualifying disabilities who request them and who otherwise meet the requirements of applicable law.  If you would like to request an accommodation during the application process, please contact our Director of Recruiting. 

All job offers are contingent on a background check screen that complies with applicable law.  For San Francisco office candidates, Ancestry will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of San Francisco's Fair Chance Ordinance.

IND2

LI#Post