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Manager, Quality & Regulatory Compliance

Job Description Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. We're currently looking for a Manager, Quality & Regulatory Compliance to join us in our Center Valley, PA office. We will also consider a field based opportunity.   Let's inspire healthier lives, together. The Manager of Quality & Regulatory Compliance will manage External audits (i.e. FDA, Notified Bodies) for various Olympus sites, develop and deliver audit and SME training, audit preparation and orchestration. As necessary, he/she will supplement Internal Audit. The incumbent will lead the tracking and trending of compliance metrics to ensure adherence and partner with key business stakeholders to identify and implement improvements. Job Duties: As a Manager, Quality and Regulatory Compliance working on the Regulatory Compliance team, you will be empowered and inspired to do your best work. You will contribute to our mission by managing External Audits, tracking and trending compliance metrics, and leading compliance initiatives. In a typical day, you will: Manage the external inspections and audit management for various sites, which will include site inspection/audit readiness and execution.  Ensure identified gaps or systematic risks are closed in a robust and timely manner. Ability to lead direct and indirect resources and build and develop team. Provide support to Internal Audits as needed. Develop metrics and compile data on audit results, issues or trends and corrective actions and present to senior management; and develop and deliver required trainings Implement proactive compliance initiatives and provide guidance to the sites, including support for Quality improvement and remediation activities. Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards.  Ensure results of monitoring process are routinely communicated to management through periodic review process. Assure all external auditing companies meet internal requirements prior to executing any portions of the contracting agreement Standardize and leverage compliance policies, practices, metrics and resources across sites. Serve on cross-site project teams consistent with company objectives to improve overall compliance performance to established metrics and requirements. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business; ensure ongoing compliance to these requirements Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed. Perform all other essential duties as assigned.    Job Requirements: REQUIRED QUALIFICATIONS:  Bachelor's Degree or equivalent in a technical or science-related field is required; Master's Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline. Minimum of 7 years of professional experience in the medical device or pharmaceutical industry is required. Minimum of 5 years of auditing experience in a medical device or pharmaceutical environment is required. Minimum of 3 years of functional management or technical leadership experience is required.  Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, SOR 98-282 CMDR (Canada), J-PAL (Japanese), European Medical Devices Directives, European Medical Devices Regulations, ANVISA 16/2013 (Brazil), TG(MD)R Sch3 (Australia), and any other regulations or standards applicable to the site is required.  Certified Quality Auditor (CQA) or Certified Lead Auditor is required. Position is located in Center Valley, PA, will consider remote candidates. Travel is be required, approximately 50%, including international. PREFERRED QUALIFICATIONS:  Proven leadership, teamwork, collaboration and influencing skills; demonstrated initiative and assertiveness. Strong project management skills. Strong computer skills and use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint).  Strong written and oral communication skills. Excellent influencing skills, presentation skills, listening skills, interpersonal skills, negotiating skills, coaching and feedback skills, and team oriented. Proven leadership skills in associate involvement and teamwork. Ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts. Ability to analyze complex data and integrate multi-disciplinary feedback. 4534BR
Salary Range: NA
Minimum Qualification
8 - 10 years

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