This position is responsible for manufacturing and product Quality activities. This position is a leadership role within the organization and is accountable for driving change, establishing sustainable business processes, improving products, and providing senior management with actionable business and product data. The position requires exceptional communication, interpersonal and project management skills to effectively coordinate activities and deliver results. This position reports to the Associate Director of Quality Assurance, San Diego.
This role requires exceptionally strong communication, interpersonal and organizational skills and a solid understanding of the application of quality regulations and standards (21CFR 820, ISO13485, ISO14971, IVDD, MDD).
This position will be a direct liaison between Mfg./Quality Operations team and Global Compliance team. The incumbent will participate in internal, customer and external audits and represent Mfg./Quality Operations team. The position will prepare, present and highlight the improvement on Quality metrics for the group and/or site. The position may coordinate/lead/execute Material Review Board meetings, Quality Management Review meetings and Monthly Metric Review meetings. The position will also own and execute Corrective Action and Preventive Action as required. As part of the responsibility the candidatewill work with cross functional team to establish manufacturing walk through and participate in continuous improvement opportunities.
- Interacts with Global Compliance Team to identify and lead compliance initiative for San Diego Site
- Participates in audits as required in the capacity of SME and/or support team member
- Builds effective, cross-functional teams that accomplish sustaining supporting and project objectives on a prescribed schedule and with a prescribed budget;
- Participates in the definition of area goals and drives teams to deliver on goals;
- Drives continuous improvement initiatives to advance quality processes and capabilities;
- Advocates strategically and operationally effective solutions to complex problems;
- Contributes quality and compliance expertise and guidance to teams responsible for addressing specific quality issues;
- Leads or provides subject matter expertise during internal and external quality system audits;
- Leads or represents functional area in Site Management Review and Quality Review processes;
- Leads or represents functional area in Material Review Board and CAPA Review Board.
- Provides senior management with plans and status updates on assigned responsibilities and goals and escalates issues in a timely fashion;
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; Establishes and supports best practices for problem solving, root cause analysis, and solution selection tools;
- Acts as a delegate for the Sr. Manager, Quality Assurance.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- 7-10 years of experience in quality assurance in a regulated environment (FDA, EMA, ISO13485); direct experience working in in-vitro diagnostic manufacturing preferred;
- Experience with presenting to external auditors is must
- Lead preparation at the site for successful regulatory inspections and third-party audits.
- Manage and reduce organizational risk to quality and compliance.
- Advocate strategically and operationally effective solutions to complex QS problems. Advise and consult on project/quality, risk and remediation plans.
- Provide compliance leadership, oversight, and strategic guidance to drive site initiatives and develop/improve procedures.
- Handles difficult personnel situations directly, using appropriate discretion, HR advice, and respect for the individual.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Experience in implementing and leveraging metrics;
- Adaptable to fast-paced, dynamic work environment and shifting demands;
- Ability to work in a matrix organization;
- Extremely strong communication, interpersonal skills and customer focus;
- Strong leadership skills with demonstrated ability to effectively work across teams and functions;
- 3-5years of experience in managing people/resources effectively to accomplish established goals;
- Proven capacity to effectively manage and escalate risk;
- Demonstrated success in a position requiring highly effective communication, facilitation and negotiation skills;
- Must be open minded, collaborative and able to work in a non-hierarchical environment;
- Must be able to look at processes high level as well as zoom in on a detailed level;
- Quality Certification preferred (e.g., CQE, CQA, SQE, 6-Sigma, Lean)
- Must be detail oriented and able to work independently
- Bachelor’s degree in an engineering or scientific discipline;
- Graduate degree in an engineering or scientific discipline and/or business strongly preferred;
- Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC);