Director, Portfolio Team Lead (6-9 month secondment)

Director, Portfolio Team Lead (6-9 month secondment)

ROLE SUMMARY 

The Director, Portfolio Team Lead leads a team of qualified auditors responsible for executing consistent and compliant audits and works to ensure that quality standards are consistently applied across the program(s). This role leads cross functional projects. 

ROLE RESPONSIBILITIES 

• Directs a team of colleagues who are responsible for leading and participating in Quality Assurance audits 

• Defines GCP Audit Strategy including the completion and documentation for the assigned portfolio 

• Selects, identifies and scopes audit entities/focused audits for assigned segment(s)/program(s)/study(s) including the proper evaluation of relevant data sources (IQMC, etc.) for input 

• Keeps current with segment/program/study specific regulatory and inspectional trends and informs/advises/participates in the audit intelligence gathering process; active participation in industry forums 

• Monitors, oversees and maintains expertise in portfolio segment(s)/program(s) 

BASIC QUALIFICATIONS

• Bachelors Degree or equivalent, preferably in pharmaceutical or natural sciences, or equivalent

• Significant relevant experience proven leadership and robust experience in auditing or quality management)

• Expert knowledge of ICH GCP, applicable global regulations, and process/program regulatory and inspectional trends

• Considered expert / thought leader for RQA in specific therapeutic area or specialty (e.g., gene therapy) and/or audit method (e.g., data management, remote trial methodology etc.)

• Demonstrates refined critical thinking capabilities (e.g., Analyzes key information, questions, and problems clearly and precisely, evaluates material with insight, uses inference to reason from given information to important implications and consequences, uses deductive reasoning consistently and with ease)

• Defines  continuous  improvement  strategy  and  operational improvement opportunities to remove roadblocks​.

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PREFERRED QUALIFICATIONS

• Master’s degree or advanced degree

• Experience in a management role preferred (or equivalent) with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.

• Experience leading audit teams

• Demonstrate experience managing T&E

• Experience growing and developing talent.

• Ability to identify risks and need for escalation.

• Ability to communicate and influence at senior director or VP level.

• Has   SME   capabilities   and   can   represent Pfizer    in   industry conferences and with stakeholders

• Able to identify correct path for stakeholder engagement.

• Experience evaluating and understanding quality standards or their application.

• Able to use technology to recognize and interpret business trends

• Provides coaching and mentoring to team members.

• Measures performance of group and holds team accountable for internal KPIs

• Grows and develop talent.

• Capable of resource management ownership

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The travel requirement may be up to 20% including international travel

ORGANIZATIONAL RELATIONSHIPS

The Director, Portfolio Team Lead has responsibility for Quality Assurance colleagues.

Externally, they will communicate and interact with Clinical Leadership, regulatory bodies, and vendor groups.

Supervision

Manages up to 10 Quality Assurance colleagues.

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!