Senior Manager, Clinical Quality Lead

ROLE SUMMARY:

This position will be responsible for managing operational Quality projects with a focus on Clinical Quality Regulatory tasks. There are many compliance tasks that will be driven independently by the individual as required within the Quality, Informatics, and Data Operations (QIDO) team. Primary support will be for the VCRD (Vaccine Clinical R&D) organization, but support will also span other areas in VRD (Vaccine R&D) including but not limited to CIHO (Clinical Immunology High-throughput Organization), CD&RWEA (Clinical Diagnostics & Real World Evidence Assays), VRD early research, and external partners.  The candidate will work with the leadership across various partner line functions (directly working with Sr VPs, VPs, and Franchise Heads) within VRD and broader PRD: Clinical Ops, Vaccine Development Management, Quality Assurance, Statistics, VRD labs, and across PRD (Pfizer R&D) to provide leadership, direction, and operational support that ensure adherence to regulatory requirements, Pfizer’s corporate policies, and procedures governing the conduct within the unit. 

The compliance lead shares the responsibility for compliance and inspection readiness with senior management and with key partner lines. This work includes Phase 0 through Phase 4 studies (post-marketing commitments and licensing studies). The major focus is compliance of the unit related to the conduct of clinical studies and the management of clinical data and especially any large-scale projects around innovating those functions. Process refinement and optimization is a critical component of the role to ensure the unit is working efficiently (with use of technology) and in compliance with regulatory standards. The individual must be open to change and collaboration, especially across the enterprise functions that manage Regulatory Quality and Compliance, with BPOs (Business Process Owners) for Clinical and Medical Controlled Documents (CMCDs) and SOPs, and with external partners/vendors/contract labs.

Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare. 

ROLE RESPONSIBILITIES:

• Accountable to develop, implement, oversee and maintain compliance inspection and audit readiness plans in collaboration with key partners

• Provide progress updates, including summarization of key audit findings and audit resolution, to leadership. Responsible for coordinating responses to deficiencies found on audits by identifying root causes of the deficiencies, developing and implementing corrective actions, and modifying SOPs to prevent recurrence of deviations and/or deficiencies found on an audit.

• Provide project management expertise to successfully develop and implement plans that ensure compliance with quality processes, procedural documentation, and electronic workflows

• Develop innovative, advanced new concepts that improve processes or products across own and related disciplines

• Collaborate with Quality Records team to ensure training compliance and curriculum management.  Proactively identify roles within Vaccine Clinical that are impacted by changes to ensure colleagues and contractors are assigned the appropriate training.

• Lead development of and identify the subject matter expert (SMEs) to assist in the development and implementation of SOPs and/or Implementation Guidelines as they relate to clinical quality

• Lead compliance aspects to biospecimen requests and destruction and partner with Biobank as appropriate

• Develop and maintain innovative approaches to managing Informed Consent and ICD to enable proper management of protocols and biospecimens. (Use of electronic workflows and how to implement them.)

• Responsible for ensuring Vaccines TMF (Trial Master File) is complete / accurate by critical study milestones

• Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies and decision making

• Maintain licenses in compliance with local regulations of the country that give support by ensuring that corporate regulatory processes, SOP’s and systems are in place

• Act as SME for site operations and support/guide for all regulations for the site testing, storage and shipment of regulated controlled substances

• Understand local regulations and developing trends in regulatory environment of the countries that support and provide assessment of the impact to key stakeholders

• Develop KPIs in order to ensure accurate and timely execution of improvement initiatives and guarantee increased compliance in relevant processes

• Support internal and external inspections and audits interfacing with company and agency professionals as appropriate

• Mentor and guide while effectively communicating complex requirements

​

BASIC QUALIFICATIONS:

• Bachelor's Degree (BA/BS) in Biological Sciences, Social Sciences, or similar field, and 9+ years of experience.  

• Relevant regulatory experience and business knowledge. ​

• Knowledge of records management in a regulated environment. 

• Demonstrated ability to manage complex/global projects. 

• Strong knowledge of an experience with ICH, FDA, EMEA and GLP/GCP/GMPs, clinical processes

• Industry experience in Clinical Operations, Clinical Design, and Clinical Research

• Expertise in problem solving, data analysis and strategic implementation

• Experience in partnering with small biotechs, research organizations, and third-party vendors

• Experience with Microsoft Office

• Strong verbal and written communication skills.

​

PREFERRED QUALIFICATIONS:

• Master's degree (MA/MBA/MS) in Public Health Administration, or similar field, and 8+ years of experience

• Doctorate (PhD/PharmD/JD) with 4+ experience

• Lean and/or Six Sigma experience

• Experience using continuous improvement techniques

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:

• Will lead weekend/night work when required in order to coordinate off urgent/business critical requests (as a support group)

• Travel may be required to vendors, collaborative sites, and/or clinical sites as needed

Other Job Details:

• Last Day To Apply: September 27, 2024

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.

Regulatory Affairs