Global Clinical Supply (GCS) Inspection Readiness Lead - Pfizer
Groton, CT
About the Job
ROLE SUMMARY
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
The GCS Inspection and Risk Management organization instills concepts of Risk Management and Inspection Readiness throughout Global Clinical Supply to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection.
The position includes interaction with a diverse range of internal stakeholders, potentially including representatives from across the Clinical Development & Operations (CD&O) organization and Medicinal Sciences.
The GCS Inspection Readiness Lead is responsible for directing and managing Inspection and Audit Readiness activities for Global Clinical Supply (GCS).
This includes close liaison with Clinical Supply Teams (CST) and PharmSci Quality Assurance colleagues to trigger and facilitate line discussions to ensure a state of program inspection readiness at all times. Establishing and maintaining engagement with Global Regulatory Affairs (GRA) Quality COE and Medical Quality Assurance (GCP quality) is critical.
The role requires understanding of GCP and GMP to support the regulatory requirements and needs of different study types, quality management, inspection readiness, audit/inspection process, clinical trial processes and systems within GCS. Strong organization and communication skills, both written and oral, are critical.
ROLE RESPONSIBILITIES
Inspection Readiness Management:
Proactively ensure that information relevant to inspection and audit readiness are initiated and maintained throughout the conduct of a protocol.
Initiate inspection readiness tools such as GCS Inspection Readiness Storyboard and further refine with the CST.
Act as the GCS point of contact with GRA Quality COE Inspection Readiness team, MQA Inspection Management team and PharmSci QA for audit and inspection preparation, response findings and required communications.
Notify GCS program and functional line SMEs of upcoming audits and inspections.
Share audit and inspection updates with GCS LT.
Coordinate and gather information during Inspections and audits, attend opening, closing, debrief meetings.
Lead meetings to address audit and inspection finding with identified SMEs.
Manage the oversight and updates of the GCS Inspection Readiness SharePoint Site for knowledge management across GCS, i.e., expected and announced audits and inspections, progress of completed work, etc.
Establish and maintain relationships with inspection and audit teams.
Lead trend analysis and lessons learned to identify opportunities and proactively share and manage components relating to GCS
Use of Spotfire or similar visualization tools in audit and inspection preparations.
Propose enhancements to visualizations to drive continuous learnings and process improvements.
Develop training and communication to maintain and evolve a culture of quality elements to ensure level of inspection readiness can be maintained.
Applies knowledge and understanding of the impact a decision will have on a process.
Assumes responsibilities outside area of expertise having broad reaching effects.
Quality Management:
Ownership of GCS Inspection and Risk Management SharePoint site for knowledge management of compliance and quality information across GCS.
Ensuring compliance with applicable SOPs and Business processes spanning Medicinal Sciences and Global Product Development (GPD) as required.
Evaluate, propose and lead process enhancements efforts.
Evaluate, propose and lead training enhancements efforts.
Escalate concerns to Head of GCS Inspection and Risk. Management and PharmSci QA related to timelines, engagement, and quality.
Work across GCS functional lines, Medical Quality Assurance and PharmSci QA to oversee, manage and deliver responsibilities.
Use of data applications to surface, highlight, manage and share information to improve quality across GCS.
Progress technological enhancements in tools used by GCS IRM.
Member of GCS Quality Governance boards or teams, including preparation and presentation of materials.
Develop and lead trending and monitoring in efforts to ensure that the conduct of clinical trials complies with stringent scientific and ethical standards.
BASIC QUALIFICATIONS
Bachelor's Degree
7+ years' experience
Demonstrated experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality.
Ability to work independently seeking guidance as needed.
Ability to function in a matrix model and in a team environment.
Diverse leadership experiences and capabilities including ability to influence and collaborate with peers, develop and coach others, and create business impact.
Strong project management, organization, planning and multi-tasking skills.
Strong written and verbal communication skills.
Technical proficiency/expertise, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing; reporting (Spotfire); and systems for document management and learning management.
PREFERRED QUALIFICATIONS
Master's degree
Regulatory inspection experience
Quality or compliance experience
Knowledge of clinical trial processes and relationships
Knowledge of GCP requirements and applicable SOPs and regulations are required
Ability to adapt to changing situations and work well under pressure
Demonstrated experience in supporting continuous improvement projects.
PHYSICAL/MENTAL REQUIREMENTS
Office work only
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel will be minimal.
This role is Groton based to support on-site inspections as required.
May include domestic and international travel to GCS sites
May periodically require working across US, EU, Asia hours to support regulatory activity and/or engagement with global colleagues.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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. This position requires permanent work authorization in the United States.
Quality Assurance and Control