Medical Quality Assurance Portfolio Team Lead at Pfizer

Job ID: 1040351

Medical Quality Assurance Portfolio Team Lead (CV & Metabolic, Immunology & Inflammation, Neuroscience and Pain, Rare Disease)

Role Description

• The CV / I&I / Rare Diseases Portfolio Team Lead (PTL) is responsible for setting the quality strategy, including inspection planning, audit strategy and quality governance for a complex development portfolio, including Pfizer sponsored research, collaborative partnerships, innovative development, and licensing arrangements.
• The Lead acts as the business and functional partner on cross functional issues and development, and drives their team to execute on the strategy.
• They help guide and develop Quality Assurance colleagues.
• The PTL acts as the MQA sponsor on special/innovative/complex projects.
• The PTL  is up to date on current industry trends, and brings a unique understanding/perspective relative to regulatory/compliance requirements within their TA.
• The Lead represents the MQA organization on the relevant governance committees.    

Responsibilities
Leadership:

• Acts as a strategic leader in Quality, influencing leadership, peers, and reports within MQA and leadership and peers across functional lines, to develop a consistent and transparent Quality strategy for the portfolio. Sets behavioral and relationship building standard for others to aspire to in MQA and Quality. Builds effective customer relationships across stakeholders and business lines. Holds their team accountable for responsibilities.
• Drives team excellence by initiating and investing in development to build a stronger and more capable organization.  Responsible for performance management. Strengthens group business acumen by providing opportunities to analyze and solve strategic business issues. Provides appropriate ongoing support to ensure that current talent develops the skills necessary to be a high performing MQA professional

Audit Strategy:

• Develops, leads and represents MQA audit strategy within Pfizer for a portfolio, and is accountable for the communication of the audit strategy across clinical leads, QALs, regulatory leads, and governance bodies
• Develops and manages complex quality programs, functional areas, and/or assessments and holds their team accountable
• Accountable for development of comprehensive audit plan across the portfolio (site,  doc, CRO audits, inspections)

Risk/Quality Management:

• Acts as a strategic partner in pro-actively identifying risks and challenges within the portfolio
• Collaborates with MQA colleagues on portfolio strategies to drive consistency across MQA
• Drive consistency and compliance with quality standards aligned with the enterprise and MQA
• Represents Pfizer MQA strategy at industry forums and regulatory agency interactions
• Analyzes and interprets quality data to distill key trends and risks, communicates findings to cross-functional leadership, provides strategic direction based on findings and implements change

Operational Excellence:

• Accountable for review of audit plans and review of complex / for cause audits  within the portfolio and holds their team accountable
• Accountable for timely reporting and close out of audit reports for direct reports
• Oversees and directs audits which may include routine, for cause, directed, and due diligence audits
• Oversees MQA support of complex investigations in collaboration with corporate compliance
• Works to ensure quality standards are consistently applied across the portfolio
• Proactively identifies and leads solutions for continuous improvement within MQA and Quality
• Maintains current knowledge of industry quality trends
• Monitors and maintains industry wide expertise of disease areas in portfolio

People Management:

• Provides current, direct, complete and actionable positive and corrective feedback to others, clearly assigns responsibility for tasks and decisions, sets clear objectives and measures, monitors process, progress and results, designs feedback loops into work
• Grow others by providing challenging and stretching tasks and assignments, is aware of each direct reports career goals, mutually constructs compelling development plans and executes them, pushes people to accept developmental moves, will take on those who need help and further development    

Qualifications

• Bachelor’s degree or equivalent experience is required.  Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered.
• 15+ years relevant experience in clinical quality management, biomedical science, clinical development, or regulatory strategy
• 5+ years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities; strongly preferred
• Expert in audits with a background in GCP, PV, GLP or other related quality areas
• Expertise in multiple quality areas preferred
• Proven ability to function autonomously in a matrix model and in a team environment
• Proven ability to think innovatively and to develop and execute strategic plans pursuant to the responsibilities of the role