Senior Manager Quality Assurance
Pfizer
Remote, Malaysia
1 hari yang lalu

Senior Manager Quality Assurance

  • Korea, Republic of - Seoul
  • APAC - Remote
  • Malaysia - Remote
  • China - Remote
  • Korea, Republic of - Remote
  • Pfizer Global Corporate Compliance Team is looking to hire an experienced Quality Assurance Senior Manager to join their team.

    Based in the UK this role is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned projects / products / vendors / PCOs (Pfizer Country Organizations) globally.

    This role is responsible to perform Pharmacovigilance (PV) and Good Clinical Practice (GCP) audits, especially at Pfizer Country Organizations, and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.

    g. US FDA, EU Directives, ICH, and National regulations).

    Reporting to the Director Quality Assurance the successful candidate will be responsible for the following : -

    Providing Leadership

  • Develops constructive customer relationship across stakeholdersMay lead teams across functional lines and consistently demonstrates effective straight talkDrives customer relationships and delivery of quality improvement recommendations for stakeholders;
  • often influences outcomes of team decisions

    Risk / Quality Management

    Strongly interacts with QA colleagues at other Pfizer locations to ensure consistency in application of the QA strategy and to promote standardization of auditing approach within QAActively engages in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venuesServes as member of project team with participation in the applicable forums, providing compliance advice and guidance to customers to achieve continuous quality improvement and effective quality controls

    Operational Excellence

    Conducts wide range and GxP (Good Practices Quality Guidelines and Regulations) complex audits with Pharmacovigilance (PV) and Good Clinical Practice in accordance with QA (Quality Assurance) risk- based processes including PV (Pharmacovigilance) audits at Pfizer sites / country organizations (PCO).

    Assesses compliance of PCO processes, clinical investigator sites, vendors, study activities, pre-clinical research activities, data, and reports and submissions.

  • Conducts QA (Quality Assurance) audits reports, returns results to project team personnel and management, and interacts with various teams to ensure corrective actions are taken to bring QA observations to closure as applicableContributes to QA by undertaking a variety of roles or assignments to further develop internal processes and peopleRoutinely suggests new audit techniques / aids in areas of technical expertise;
  • strong ability to operationalize create ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinkingActively supports regulatory inspections or corporate audit activities as requiredProvides subject matter expertise representing MQA (Medical Quality Assurance) at cross-functional forums and / or projects as endorsed by MQA management

    Qualifications

    Bachelor’s degree or equivalent experienceRelevant pharmaceutical experience (i.e. Pharmacovigilance, Auditing, Good Clinical Practices, drug development, clinical and / or non-clinical research, regulatory compliance) including previous Pharmacovigilance / clinical Quality Assurance experience conducting a broad range of audits

    Please note that travel of up to 30 % - 50% will be required to carry out this role successfully.

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    Application Deadline :

    Please apply via Pfizer Career Website Only.

    LI-PFE

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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