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Grifols Shared Services North America, Inc Senior Manager QA in San Diego, California

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Summary:

Functional lead for the Grifols Diagnostics San Diego site to ensure that all aspects of the operational business comply with cGMP regulatory requirements, ISO standards, and the Grifols Diagnostics Quality Manual. Reports on the status and completion of the San Diego site responses and commitments from audits (internal and external), tracks trends and monitors the effectiveness of actions taken. The position will also provide support for audits of San Diego site by customers, corporate auditors, notified bodies and regulatory authorities. Assists in the development, implementation, and continuous improvement of the compliance profile of the San Diego quality system.

Primary responsibilities for role:

  • Responsible for managing a team to conduct quality system and compliance activities.

  • Responsible for managing all regulatory Health Authority inspections, responses and follow-up actions. Support business unit and ensure readiness for regulatory inspections.

  • Interaction with regulatory and partner auditors/inspectors.

  • Responsible for managing all Grifols internal and customer audits, responses, and follow-up actions.

  • Responsible for the San Diego self-inspection program including the procedures, audit schedules, audit reports, and observation follow-up and closure.

  • Ensure that the Self Inspection schedule is inclusive of all GxP related activities and that the frequency of inspection is aligned with the level of operational risk determined for each area and is integrated with existing quality systems.

  • Support customer audits, responses, and follow-up actions.

  • Locally support and supervise GMP upgrade projects and ensure compliance with global standards.

  • Locally manage San Diego Documentation System (DCM) for review and approval of documents.

  • Lead, develop and support global quality programs in Diagnostics in alignment with business objectives.

  • Provide guidance in remediating compliance deficiencies.

  • Create and maintain operational metrics related to quality system compliance, lead organization of management reviews and follow up action items.

  • Maintain quality system training metrics for the San Diego site.

  • Provides guidance and interpretation of regulatory regulations as they apply to Grifols Diagnostics San Diego site.

Knowledge, Skills, and Abilities:

  • Excellent communication skills as well as strategic and conceptual thinking.

  • Knowledge of regulations and standards affecting IVDs.

  • Experience with project management (problem solving and resolution) and general business principles.

  • Understands the global implication of failure investigation.

    • Training in leading audits and experience as lead auditor or interacting with Health Authorities and/or CQA/CQA Biomedical a plus.
  • Excellent people management and communication skills as well as strategic and conceptual thinking

  • Advanced computer skills to visually ease data communication and conclusions, such as Excel, Visio.

Education:

Bachelors Degree, preferably in life or physical sciences experience in a clinical laboratory, diagnostic, quality or technical area

Experience:

  • 10-12 years of experience in management of quality system in a regulated (GMP/ISO/QSR) industry and minimum of 5 years’ experience managing a team.

  • Knowledge of regulations and standards affecting medical devices/ IVDs including ISO 13485, EU In-Vitro Diagnostics Regulation or Medical Device Directives and FDA regulations

  • Training in leading audits and experience as lead auditor or interacting with Health Authorities or other external auditors.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 218549

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