Associate Director, Quality Assurance

Scope:

Manage the day to day activities of Quality Assurance department. Provide professional and efficient quality service to Sekisui Diagnostic’s teams; manage the QA Manager, Supervisor, QA documentation and their direct reports to ensure all QA activities are prioritized properly and executed in accordance with required timelines. Oversee the site’s quality management system and act as the local Management Representative for the Quality Management System (QMS).

Responsibilities:

Includes, but is not limited to, the following responsibilities

· Maintaining and where appropriate, improving quality standards, directives and policies for Sekisui Diagnostics.

· Supporting the Sekisui Medical Group made up of teams from the North America, Europe and Asia - this may include helping to enhance the Quality System operations and/or harmonization of Sekisui sites on a global scale. Participates on global teams (i.e. QCDEP) as required.

· Coordinating with the Corporate and/or local quality groups to harmonize local policies and systems.

· Acting as the appointed Management Representative who has established authority over and responsibility for ensuring the quality system requirements are effectively established and maintained in accordance with the ISO standards, CDMR, FDA QSR 820, EU regulations, Australia, Japan, etc.

· Coordinate and lead all external audits at the PEI site (customer, regulatory and compliance audits).

· Managing the day to day activities of direct reports (i.e. QA Managers, Supervisors, and their direct reports)

· Chairing the Product Review Board (PRB). Utilizing the PRB to help decide the disposition of materials that have been subject to deviations of any kind.

· Managing all aspects of the internal non-conformance management systems specially CAPA, deviations, risk assessments, OOS, Supplier Corrective Action Reports and Plans (SCARs) or Supplier Questionnaires, etc.

· Recommending corrective actions to support continuous improvement program.

· Works closely with OEM customer in relation to projects, continuous improvement initiatives at the site.

· Overseeing and managing the internal audit program; Performing supplier audits.

· Reviewing controlled documents such as quality manual, quality policies, standards and regulations, etc. as per the periodic document review requirement.

· Delivering quality training to new employees or as required.

· Evaluating and challenging the quality system and practices within the site. Working to continuously improve the efficiency of both of those systems and where necessary their levels of compliance.

· Participating in site or global project teams to provide QA guidance and support.

· Ensuring that all QA Documentation related procedures reflect current practice clearly and accurately.

· Support of the new product development, which includes oversight (but not ownership) of the design control process, working in partnership with Research and Development.

· Attending the Customer Service Review Board (CSRB) meetings.

· Reviewing the new or revised labels or inserts and sending the notifications to the appropriate people.

· Reviewing Site Master Validation File (SMVF)

· Providing leadership and direction in the QA department, which includes external Business to Business meetings, Trade shows, site meetings.

· Driving continuous improvement for processes and product quality performance.

Education / Experience:· Master’s or Bachelor’s degree in health science or an engineering related field.

· Minimum 10-15 years progressive management experience in Quality Assurance area, preferably in a diagnostics or pharmaceutical management environment.

· Experience of managing a team of direct reports, which includes individual/team mentoring and development planning.

· Experience with management of department budgets and capital expenditure planning.

Skills / Pre-requisites:

· Expert knowledge of the Quality Assurance system including Quality System Regulation CDMR, 21 CFR Part 820, MDSAP, ISO 9001, ISO 13485 and EU regulations, as well as, familiar with Australian and Japanese regulations.

· Experience with the manufacture of diagnostic reagents

· Experience of managing regulatory audits from customers or regulatory or compliance agencies.

· Experience with instrumentation, either diagnostics analyzers or medical devices that have both a hardware and software/firmware component; also including the development of new instrumentation (and associated reagents).

· Familiar with the management, improvement and harmonization of quality systems

· Well-developed organizational/planning skills.

· The ability to analyze complicated situations and development actions plans for the mitigation and/ or recurrence of these situations.

· Efficient with the use of Microsoft Office Suite – including Powerpoint, and Visio.

· Ability to effectively interact with and present to senior management at all levels, as well as to external audiences/customers and auditors/inspectors.

· Strong interpersonal, communication, negotiation and problem-solving skills.

· Experience working in a multi-national corporation and/ or Japanese lead business.

· Lead or Internal auditor training (preferred).

· Lean or Six Sigma green or black belt training (certified preferred)

· Formal training in root cause analysis, 8D, 5 Why, Fish Bone, etc.

· Design of experiments (DOE) or similar problem-solving approaches

· An understanding of statistics as they apply to the development of sampling plans; familiar in the use of software programs

such as JUMP or SAS. (preferred)