|

Get new similar jobs by email for

Sr Manager Quality & Complianc...

Monster
 
 
 
 

Job Summary

Company
Pfizer
Location
New Haven, CT
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4903_4704433

Sr Manager Quality & Compliance

About the Job

Position summary:

The Pfizer Clinical Research Unit (PCRU) Quality and Compliance Manager (QCM) is the PCRU specialist dedicated to Inspection Readiness and Continuous Improvement, collaborating with colleagues across Pfizer. The QCM is responsible for the delivery and execution of the quality program at the PCRU. This role is responsible for Good Clinical Practices (GCP) oversight and for assuring compliance projects and programs with Pfizer Standard Operating Procedures (SOPs), Policies and all applicable worldwide regulations and guidelines (US  FDA, EU Directives, ICH and National regulations) as they relate to PCRU Study Operations.

This position is responsible for internal quality and compliance reviews (SOPs, interviewing appropriate personnel, inspecting the facility, and/or reviewing study documentation) and for the communication and report out of such activities (compiling observations) including any follow up needed (CAPA completion).

Interaction with:  A diverse range of stakeholders from varying internal lines as well as external committees or subgroups; represent Pfizer globally

Ability to:  influence the organization globally and lead and/or influence industry

Understanding/knowledge of: GCP, clinical trial processes and systems, CAPA, quality issues, Root Cause Analysis, local and multi-country regulatory requirements, quality management, inspection readiness.

Responsibilities:

Quality

Quality Management System

  • Leads initiatives relating to a total Quality Management System by undertaking a variety or roles and assignments to further develop internal process.  Ensure appropriate coverage of the PCRUs in the Pfizer Company wide GCP Quality Management System (GCP-QMS)
  • Will work with the Leadership and colleagues within the Pfizer organisation as necessary to develop and maintain processes enabling studies conducted at the PCRUs to meet Pfizer standards, ethical standards, ICH, regulatory and legal requirements

Quality Performance Analytics

  • Defines and conducts internal quality and compliance reviews, reports results to PCRU LT and interacts with various teams to ensure corrective actions are taken to bring observations to closure
  • Identifies and initiates ways to improve internal quality and compliance reviews and processes

Procedures

  • Maintains working knowledge of relevant SOPs and GCP regulations and guidelines on both a local and global level
  • Serve as a liaison between PCRU Study Operations and CTPQ regarding process changes and implementation that impact studies at the Units
  • Oversee the development, deployment, updating and maintainence of PCRU specific CMCDs

Inspection/Audits

  • Ensure the PCRUs are Inspection Ready; identify and ensure implementation of best practices throughout the industry where appropriate as well as ensure unit wide understanding of global inspection readiness
  • In concert with the PCRU LT, coordinate or host all audits / inspections within the PCRU
  • Support CAPA identification and implementation

Other PCRU Specific Responsibilities

  • Support an environment of Continuous Improvement at the PCRUs
  • Chairs both the local and global Continuous Improvement Group, providing compliance advice and guidance to PCRU to achieve continuous quality improvements and effective quality controls
  • Interacts with counterpart to ensure consistency in application of the quality strategy and to promote standardization across PCRUs
  • Leads special assignments on various projects and work streams as determined by PCRU LT

Compliance

  • Assesses compliance of PCRU in accordance with ICH, applicable government agency regulations/guidelines, as well as Pfizer policies, procedures, and industry standards on a global level
  • Conducts external compliance reviews, where applicable (e.g. couriers, technology providers)
  • Verify training compliance and work with line manager(s) to ensure PCRU staff meet training requirements on a continuous basis
  • Ensure adherence to current CAPA commitments as applicable to the PCRU

Training

  • Identifies, defines and delivers awareness sessions on various GCP topics internally
  • Maintain administration related to PCRU specific training
  • Act as SME as appropriate
  • Provide support in form of liaison and troubleshooter for existing Pfizer training systems

Efficiency

  • Lead and/or support efficiency and continuous improvement initiatives (for PCRU and PCRU Study Operations as a whole where appropriate)
  • Engages in appropriate activities to influence and meet the changing needs of the regulatory environment

Additional responsibilities

  • Drives and takes lead for cross site initiatives, new activities and focus areas
  • Interprets industry standards and uses that knowledge to further not only Pfizer’s phase 1 units, bu also externally influence this particular part of the industry
  • Represents both PCRUs in company wide related initiatives
  • Specialized in process efficiency methodology (e.g. Six Sigma)
  • Compliance Champion (FCPA, MAPP) for the PCRU in collaboration with Compliance Manager and Legal in local commercial organization
  • Quality representative in local Pfizer and external environments (e.g. professional organization and regulatory authorities)

Organizational relationships:

  • Reports to PCRU Study Placement Director but also has a dotted line to the PCRU medical directors at both units, as well as the Vice President of PCRU Study Operations. 
  • Will support PCRU LT / PCRU Study Operations in quality and Inspection Readiness initiatives as appropriate
  • Collaborates with other Pfizer departments focusing on quality and Inspection Readiness Initiatives as appropriate
  • Member of CRU leadership team at assigned site and PRCU Operations eLT

Qualifications:

  • Experience: In general candidates for this job should have the following levels of education and relevant experience:
    • A scientific or technical degree (MS or BS), with 5 years experience in a similar role
    • Experience in developing quality management plans
    • Experience with SOP and training implementation
    • Experience conducting, managing or participating in regulatory inspection processes
    • Experience with inspection readiness
    • Experience managing multiple complex projects
    • Experience implementing processes and procedures on a local and global basis
    • Comprehensive knowledge of  ICH-GCP practice
    • A strong working knowledge and understanding of drug development processes
    • Certification in Lean Six Sigma tools and methodologies is a clear asset
    • Fluent in English, both speaking and writing is a must
    • Fluent in French and/or Dutch
    • Strong communication skills
    • Strong project management skills

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.

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

 

Job Tools