Pfizer Medical QA Professional (QA Manager) in Groton, Connecticut

The Quality Assurance Professional (QAP) position is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned projects/products/vendors/PCOs. This role is responsible for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and/or Pharmacovigilance (PV) oversight, 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).

  • Conducts scheduled audits in accordance with QA (Quality Assurance) risk-based processes.

  • Assesses compliance of clinical investigator sites, vendors, study activities, pre-clinical research activities, data, and reports, submissions, and PCO (Pfizer Country Organization) processes against ICH (International Conference of Harmonization), applicable government agency regulations/ guidelines, as well as Pfizer policies, procedures and industry standards. Comprehensive working knowledge of Quality Assurance, regulations and auditing.

  • Conducts QA (Quality Assurance) audits reports, 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 applicable.

  • Audit preparation and notification to key stakeholders (e.g. review of audit and inspection history and SOPs)

  • Conducts audits of clinical investigator sites, nonclinical laboratory studies and vendors of same.

  • Conducts audits of regulatory documents and marketing applications.

  • Conducts PV (PharmacoVigilance) related audits at Pfizer sites/country organizations, and vendors.

  • Conducts risk assessments of licensing and/or acquisition products/compounds.

  • Conducts audits of vendors (e.g. CROs (Contract Research Organizations), Phase 1 facilities, etc.)

  • Conducts for-cause, directed audits and complex audits

  • Serves 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.

  • Develops constructive customer relationship across stakeholders; may lead teams across functional lines and consistently demonstrates effective straight talk.

  • Develops and delivers awareness sessions with minimal supervision on various GCP (Good Clinical Practice), GLP (Good Laboratory Practices), PV topics internally and externally.

  • Acts as a strong technical resource and is called upon to resolve GCP/GLP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, GLP, PV regulations and guidelines as well as local regulations.

  • Consistently demonstrated expertise in the use of different Pfizer systems.

  • 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 QA.

  • Contributes to QA by undertaking a variety of roles or assignments to further develop internal processes and people.

  • Routinely 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 thinking.

  • Design and actively participate in special assignments on various project teams and work streams as determined by QA management.

  • Drives customer relationships and delivery of quality improvement recommendations for stakeholders; often influences outcomes of team decisions.

  • Actively support regulatory inspections or corporate audit activities.

  • Ensures rapid communication of QA issues, including potential misconduct or issues of significant deviation with projects/products, to appropriate leaders and colleagues.

  • Provides training and mentorship to less experience members of MQA (Medical Quality Assurance) staff.

  • Actively engage in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues.

  • Exemplify ability to work in a culturally diverse environment.

  • Exemplify OWN-IT behavior and promote an OWN-IT culture.

  • Effective participation in endorsed, non-project initiatives external to MQA that have significant, measurable deliverables.

  • Oversight of key, management-endorsed, internal MQA work streams or projects.

  • Subject matter expertise representing MQA at cross-functional forums and/or projects as endorsed by MQA management.

  • Requires approximately 40-60% time for conducting audits (including travel) and attending QA meetings.

QUALIFICATIONS

  • Bachelor's degree or equivalent experience

  • 5-7 yrs. relevant experience in the pharmaceutical industry or related field (i.e., clinical research, previous audit experience, previous experience in a quality role position, etc.)

Additional Offer Details:

  • Last Date to Apply for Job: 7/28/17

  • Grade: 10

  • Additional Location Information: ARG - Buenos Aires, Planta; ARG - Buenos Aires, Thames Office Pk; AUS - NSW - Sydney - Hospira; AUS - VIC - Melbourne - Hospira; BRA - São Paulo - CENU; BRA - São Paulo - Hospira; BRA - São Paulo - Matriz - Dumas; CAN - QC - Kirkland - Canadian Head Office; ESP - Barcelona; ESP - Madrid; GBR - Sandwich; KOR - Seoul Head Office; POL - Warsaw; ROU - Bucharest; RUS - Moscow; USA-IL - Lake Forest H4 - HSP; USA - MA - Boston; USA-MA-CambridgeKendall Sq-610; USA-MA-CambridgeKendall Sq-700; USA-MA-Cambridge Technology Sq; USA - NY - New York City; USA - PA - Collegeville

  • Eligible for Employee Referral Bonus

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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