Pfizer
Senior Manager Management Notification and Recall Lead
🇺🇸Groton, Connecticut, United States13 days ago
$124K – $207KSeniorFull Time
Use Your Power for Purpose
In support of Management Notification and Market Action processes, this position will be located in PSOQ -PharmSci Operation Quality, responsible for leading efforts to manage escalated Quality incidents by leveraging cross-functional partnerships with Global Clinical Supplies, Clinical Development & Operations, other Worldwide Research and Development organizations, and PGS.
Recall LPO
The role will assume primary responsibility and accountability as the Local Process Owner (LPO) and Subject Matter Expert (SME) within PSOQ for market actions and stock recovery. As PSOQ Market Action LPO, the role will be accountable for process ownership, development/continuous improvement, health/maintenance, governance, and training (as needed).
Market Action Global Process interface
This position will represent PharmSci by interfacing with Global Process Owner(s) to ensure that the needs of PharmSci are embedded within global process documentation. Specifically, the role will be responsible for liaising such that fit-for-purpose requirements of materials used in a Pfizer clinical trial (e.g., Investigational Product (IP), commercial drug products, and components) account for PharmSci’s perspective through the incorporation of local needs, best practices, and regulatory expectations.
Management Notification and Escalation
In support of the immediate Clinical Complaints & Investigations team, the role will act as the SME to
Inform/advise on escalation decision making
Lead escalated Management Notification activities (e.g., Cross Functional Triage Team interactions, Triage summary form completion, and Quality Review teams
Assess preliminary Board of Health requirements
Lead as primary interface with the Escalating and Reporting team within QSEO
This role will provide support across PSOQ as the SME/consultant for Management Notification activities and manage Complex Clinical investigations and complaints, particularly those that feed into QRT ( Quality Review Team)/ Recall decisions,
In addition, the role would be required to Lead Inspection/Audit readiness, also responsible for developing and enhancing processes to continuously improve and streamline existing quality processes to support activities, with knowledge and skills contributing towards the goals and objectives of the team
What You Will Achieve
Lead for Global Clinical Supply (GCS) Quality Assurance, for Quality Review Teams (i.e., Area Quality Review Team (AQRT), PharmSci Quality Review Team (PSQRT), and product recalls
Local Process Owner (LPO) for recalls and stock recovery process within PSOQ, acting as the Subject Matter Expert accountable for process ownership, training, process health, governance, and continuous improvement
Primary interface with the Escalating and Reporting team within QSEO for management notification activities
Act as a support/ Liaison/ consultant across PSOQ functions, for activities required within Cross functional Triage Team, Triage Summary Form completion and Quality Review Teams, also those impacted within mentioned team
Responsible for leading /supporting the author, reviewing, and approval of related Complex GMP deviations & product quality investigations and providing oversight to the timely closeout and effective investigation of clinical supplies, CAPA effectiveness, change control, trending, and metrics
Responsible for leading /supporting the author, reviewing, and approval of Complex clinical complaints, ensuring timely closeout, providing complaint management oversight for trending and metrics
Review/Approve PSOQ global procedures that may impact quality systems and quality of Investigations and Clinical complaints. Work to develop procedures/processes that increase efficiency and maintain high-quality standards.
Takes appropriate risks to Streamline compliance and simplify procedural and other requirements to ensure ease of following program requirements
Manage your own time to meet agreed targets and develop plans for work activities within matrixed teams inclusive of Pharm Sci, PGS, Regulatory, GCS
Make GMP and GCP compliance and Quality decisions independently to resolve complex issues
Provide direction and support to PSOQ /GCS relative to a constant state of inspection of readiness. Lead/Participate in audits/inspections
Recognize when an issue is beyond your sphere of influence and escalate PSOQ LT leaders
Participating in or leading Limited Duration Teams, Right First Time (RFT), and Continuous Improvement projects, Corrective/Preventative Action Effectiveness, etc. which may be PSOQ-centric or cross-functional where impact may often be global in nature
Lead and support initiatives that contribute to strengthening quality culture from a global and site perspective across Pharm Sci and PGS sites. Practice and encourage quality culture behaviours within quality and the business lines
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience.
Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
Experience with GMP electronic systems and tools.
Experience and Talent in influencing and negotiation skills.
Ability to work independently as well as in a team environment within own team and interdepartmental/matrixed teams.
Excellent communication and interpersonal skills.
Proactive approach and strong critical thinking skills.
Effective written and oral communication skills.
Demonstrated experience in leading continuous improvement projects.
Proven ability to function autonomously in a matrix model and in a team environment.
Proven ability to think creatively and to execute and manage strategic plans.
Work Location Assignment: Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
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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.
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Quality Assurance and Control
