13 days old

Senior Manager, GCS Risk Management Lead

Pfizer
Groton, CT 06340
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**Why Patients Need You**



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.



**ROLE SUMMARY**



The GCS Quality Management Group instills concepts of Risk Management and Inspection Readiness through Global Clinical Supply to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection.



The GCS Risk Management Lead works as a close liaison with Clinical Supply Teams (CST) and PharmSci Quality Assurance colleagues to facilitate line discussions and ensure quality state of identification, mitigation and maintenance of risks. The position includes interaction with a diverse range of internal stakeholders, potentially including representatives from across the Global Product Development (GPD) organization and Medicinal Sciences.



This includes close liaison with Clinical Supply Teams (CST) and PharmSci Quality Assurance colleagues to trigger and facilitate line discussions to ensure state of program inspection readiness at all times.



The role requires understanding of GCP and GMP to support robust risk management relevant to Investigational product, including clinical trial processes and systems within GCS. Strong organization and communication skills, both written and oral, are critical.



The role requires understanding of GCS functional lines and interdependencies to identify and estimate the appropriate risks to clinical trials. It is also important to understand the different internal and external factors that can affect its performance.



Risk Management Lead: Proactively ensure GCS risk tools are triggered, deployed, maintained and prioritized for the entirety of a clinical program, example GCS risk register and Formal/Informal Quality Risk Management (QRM) risk assessment.



+ Lead evaluation of risk approach and tools to propose and/or lead enhancement efforts

+ Develop and utilize improved risk and predictive analysis to identify and manage risk to prevent occurrence of repeat issues.

+ Use of systems and visualization tools (i.e., Spotfire), to evaluate quality information, identify common risks, trends and communicate findings. Including recommending/implementing enhancements.

+ Generate trends, share appropriately and drive to understand to mitigate frequent risks across programs

+ Review and share common Therapeutic Area risks including those surfaced by study team in study team risk log

+ Develop and deliver presentations to GCS lines, leadership and Quality councils as needed

+ Autonomous and gets selective input to aid in decision making, able to grasp the fuller picture. Identifies key stake holders to gain their viewpoint before making a decision.

+ Develops contingency plans, thinks through implications and approaches to lessen any anticipated risks to work group/project team.



Quality Management



+ Ensuring compliance with applicable SOPs and Business processes spanning Medicinal Sciences and Global Product Development (GPD) as required.

+ Lead efforts to evaluate and propose process enhancements

+ Lead efforts to evaluate and propose training enhancements

+ Appropriately escalate concerns to Head of GCS Quality Management and PharmSci QA related to timelines, engagement, and quality.

+ Work across GCS functional lines, Medical Quality Assurance and PS quality to oversee, manage and deliver responsibilities

+ Use of data applications to surface, highlight, manage and share information to improve quality across GCS

+ Liaise with GCS Digital Business Operation and PS QA to progress technological enhancements

+ May participate in 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.

+ Utilize and share learnings, perform lessons learnt from inspections to advance inspection readiness. Seek to advance GCS risk approach.

+ May be required to support product quality investigations and provide oversight to the timely closeout and effective investigation of clinical supplies, CAPA effectiveness, change control, trending and metrics



Basic Qualifications



+ A minimum of a BA or BS is required, advanced degree in relevant field desirable.

+ Minimum 9 years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality, risk and issue management

+ Risk, quality or compliance experience

+ Strong and effective verbal and written communication skills.

+ Strong project management, administrative, and technical capabilities

+ 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:



+ Ability to work independently seeking guidance as needed

+ Detailed knowledge of clinical trial processes and relationships

+ Knowledge of GCP requirements and applicable SOPs and regulations are required

+ Risk management skills including defining and leading risks and mitigation efforts

+ Influencing skills

+ Attention to detail

+ Strong scientific background in Life Sciences, Risk Management, or higher degree preferred

+ Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills

+ Ability to adapt to changing situations and work well under pressure

+ Proven ability to function autonomously in a matrix model and in a team environment

+ Demonstrated experience in supporting continuous improvement projects.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Travel will be minimal.



May include domestic and international travel to GCS sites.



May periodically require working across US, EU, Asia hours to support activity and/or engagement with global colleagues.



**OTHER JOB INFORMATION**



+ Last Date to Apply: June 14, 2021



\#LI-PFE



**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.



Quality Assurance and Control
Posted: 2021-06-01 Expires: 2021-07-02
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Senior Manager, GCS Risk Management Lead

Pfizer
Groton, CT 06340

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