Senior Asset Quality Lead, Inspections (Director)

The Senior Asset Quality Lead, Inspections (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of-sight for assigned asset/franchise The Senior Asset Quality Lead /TA. With this focus, the sAQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the sAQL will ensure asset and/or franchise quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The sAQL is the point person to the cross functional asset/franchise and other relevant stakeholders for quality risk management, quality issues management and general GCP guidance. The sAQL may also provide protocol level quality support. The sAQL may also serve a subject matter expert within CD&O Quality and represent the group at relevant initiatives/governances.

Asset/Franchise-Level Quality Oversight

 · Provide input and support to asset-assigned AQLs to ensure clinical development plan strategy and asset-level risks are incorporated into study and asset-level risk management and oversight to support GCP compliance

· Strategically utilize quality measures/data to monitor asset/franchise quality and identify potential risks/quality trends across the asset/franchise and report out to applicable governance bodies

· Serves as point of escalation for GCP quality accountability within asset/Franchise

· Monitor submission risk and flag major risks for Category Quality Head review and other key stakeholders for review.

Asset/Franchise-Level Oversight of Study-Level Risk Management Plan Development

· Ensure consistency of the study risk plans across the asset and/or franchise, including relevant vendor and site level risks.

 · Develop and present quality point of view at governance and portfolio related meetings Inspection Readiness, Preparation and Support

· Provide strategic expertise to AQLs/study teams as they complete Inspection Readiness (IR) activities

· Develop and maintain Pfizer’s inspection readiness strategy including tools and processes.

· Train and mentor AQLs regarding inspection support activities and development of written responses to findings.

· In conjunction with IMQA, coordinate business line inspection support activities including but not limited to requests for dossiers, pre-inspection requests, during inspections and through the development of written responses to findings.

Business Development/Integration/Divestitures

· GCP quality representative of the PRD due diligence team for business development opportunities.

· Partner with PRD leaders and cross-organization Quality leaders to assess development program strategy and key quality risks to inform the assessment of opportunities for the category

· Drive identification of key quality risks and proposed mitigations related to acquisitions and incorporate into study level risk planning as well.

· Provide strategic input to risk-based quality approaches

· Provide quality leadership during integration activities

 · Lead Quality Integration activities including but not limited to: representing quality functional lines at integration workshops or operational workshops, leading the GCP Quality Integration sub-team, developing and leading GCP Quality Integration Workstreams, and managing quality project plans for GCP business deal activities (e.g., integration operations).

Escalation, Communication, and Governance

· Set strategic framework for quality communication within asset/franchise, including content and structure of leadership updates

· Develop and present quality point of view at governance meetings

 · Advise asset/study team on appropriate escalation pathways for quality concerns

 · Communicate key quality information (e.g. inspection/audit learnings) across asset/franchise and serve as asset quality expert

· Represent Category Quality Management at Category level meetings and other functional level leadership meetings, as delegate for Category Quality Head

· Lead asset level/franchise level quality risk planning activities

· Support Category Quality Head in defining optimal resourcing strategy and GCP quality support within Category.

support within Category

Subject Matter Expertise

· Serve as a CD&O Quality point of contact and technical expert for Quality related processes and/or systems (could include inspection readiness/support; business development/ integrations; quality risk management; regulatory interaction/response management)

· Accountable for maintaining training and CD&O Quality process related documentation

· Train and mentor AQLs related to SME area · Work with Category Quality Heads to ensure appropriate resourcing related to SME area.

FSP Resource Management

· Manage FSP resource staff for clinical quality group

· May manage FTE resources for assigned therapeutic area sAQL may also have standard AQL responsibilities and be assigned to studies within the portfolio.

BASICQUALIFICATIONS

A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:

*Preferred 15 or more years of relevant experience o BS –10+ years or equivalent

*MS/MBA – 9+ years or equivalent • Highly skilled at building strong network/ knowledge/ relationships with internal/external stakeholders

• Expert advanced knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness

• Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines

• Familiarity with the relevant key therapeutic area(s) Preferred 15 or more years of relevant experience o BS –10+ years or equivalent

PREFERRED QUALIFICATIONS

• Extensive clinical trials experience, especially operational processes and/or systems.

• Strong interpersonal skills, ability to influence, engage leaders and ability to establish and maintain excellent working relationships across lines in a matrix organization

• Experience of leading global initiatives or project teams.

• Appreciation of diverse needs of different regulatory requirements of various sites and countries

• Cross-functional leadership experience • Advanced Quality Management experience including use of metrics to drive quality and compliance

•Extensive quality-related experience including expert knowledge in areas of: o Quality and compliance management o Root Cause Analysis o Metrics development and utilization o Inspection Readiness, Inspection conduct and CAPA response process o ICH GCP, and Regulatory obligations

• Excellent understanding of Pfizer processes and SOPs

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate. Partners with key stakeholders within Clinical Development & Operations, RQA, Data Sciences and Analytics, Global Clinical Supply and and BPOs

May manage FTE’s and/or contract resources (FSPs)

The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.

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.

Quality Assurance and Control