The Global Medical Quality Excellence Director is responsible for quality initiatives of identified medical activities (i.e. Publications, Medical Information, Promotional Materials, Expanded Access, Independent Medical Grants, etc.) across Medical in Worldwide Medical & Safety (WMS), Business Unit (BU) Medical Affairs and Pfizer Country Office (PCO) Medical, including the development and implementation of policies, standards, processes and guidelines that adhere to laws and regulations. This position reports to the Global Medical Quality Excellence Lead within the Global Medical Quality Governance (GMQG) organization and assists with the development of global quality plans and uses dashboards and other methods to ensure quality and compliance with those areas in the Medical Affairs Quality Oversight Committee (MA QOC). The Director champions quality and compliance in alignment with the QMS as well as Corporate, Regulatory, and Healthcare Compliance policies and procedures. The Director provides support to Medical Business Process Owners (BPOs) globally to foster quality and consistency of processes across Pfizer. The role drives risk management, quality management, compliance, process improvements and quality oversight aligned with Pfizer's quality governance framework. This position works cross functionally with the GMQG regional and medical monitoring leads and assists with the development and oversight of quality plans and quality event management.ROLE RESPONSIBILITIES Development and Implementation of Standards, Processes and Guidelines
Coordination with Global Medical Quality Governance (GMQG) colleagues and other Stakeholders
- In partnership with the Global Medical Quality Excellence lead, ensure delivery of the quality plans and risk mitigation efforts for identified medical activities.
- Collaborate with Medical in WMS to determine the SOPs and other critical policy/process documents that need to be developed and/or updated and establish prioritization.
- Develop dashboards for monitoring risk mitigation activities and metric reporting for key performance indicators in alignment with Medical Affairs Quality Oversight Committee (MA QOC).
- Provide support on internal and cross functional projects.
- Communicate with GMQG counterparts to share knowledge and best practices and to address issues that cross multiple groups.
- Partner with Medical Quality Governance Managers (MQGM's) in support of PCO quality plans that impact Medical areas (i.e. Medical Affairs Governance, Medical Information, Independent Medical Grants, Promotional Materials, Expanded Access and Publications).
- Provide expertise, consultation and recommendations on quality standards issues to both Global HQ and PCO colleagues as needed to improve the quality of processes at the local level, facilitate uniform standards globally and reduce duplication of efforts.
- Occasional teleconferences outside of normal working hours maybe required.
- Interact with Corporate Audit, Regulatory Quality Assurance (RQA), Corporate Compliance, and Legal regarding regulatory and audit issues and assist with the response to compliance and process related legal requests.
- Manage audit related activities including audit preparation, resolution of audit observations/remediation plans and liaison with the auditors through all stages of the audit (pre-audit activities, fieldwork, and post audit management of remediation plans).
- In partnership with the Regional MQG leads, provide strategic direction to MQGMs and support their role on audit/inspection related activities and support PCO groups in preparation for audits and with audit resolution as needed. Support Medical areas impacted by external inspections (US and PCOs) and assist with resolution of any issues identified. In partnership with GMQG leadership and BPOs, identify trends related to audit findings, Quality Events/Significant Quality Events (QE/SQE), deviations, etc. to ensure timely action and resolution from MQGMs and process owners.
- Partner with stakeholders to develop and manage CAPA plans (originating from audits, inspections or Quality Events) and CMCD Exceptions.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Bachelor's degree with 10+ years of pharmaceutical industry experience and at least five years of experience in internal audit, assurance, or quality standards, including leadership experience
- Expertise in relevant operational processes and industry best practices of internal control and risk management and assessment
- Demonstrated success in developing/redesigning processes and measuring effectiveness and efficiency
- Strong written and oral communication and presentation skills
- Strong organizational and analytical skills
- Strong relationship management skills with demonstrated ability to influence and negotiate outcomes
- Proven leadership ability to manage multiple projects with a clear sense of priorities and respect for deadlines
- Ability to perform in a team and matrix organization and adapt to a dynamic environment
Other Job Details:
- Advanced academic degree in science, health, business, or technology-related field with equivalent relevant professional experience preferred
- Prior audit experience preferred
- Basic knowledge of key Pfizer Medical processes including but not limited to: Medical Information, Medical Affairs Governance, Independent Medical Grants, External Funding, Publications, Expanded Access, Promotional Materials and Transparency
Last Date to Apply for Job: June 18, 2021
Additional Location Information: New York, NY; Collegeville, PA; Groton, CT; Peapack, NJ
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