Job at Pfizer for a Medical Quality Assurance Portfolio Team Lead
Pfizer - Good health is vital to all of us, and finding sustainable
solutions to the most pressing health care challenges of our world
cannot wait. That's why we at Pfizer are committed to applying science
and our global resources to improve health and well-being at every
stage of life.
We strive to provide access to safe, effective and
affordable medicines and related health care services to the people who
need them.
Pfizer is recruiting to fill the job position below:
Job Title: Medical Quality Assurance Portfolio Team Lead (CV
& Metabolic, Immunology & Inflammation, Neuroscience and Pain,
Rare Disease)
Job ID: 1040351
Location: Nigeria
Full-Time: Regular
Role Descriptions
- 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 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.
- 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.
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
- 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
- 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
Operational Excellence:
- Accountable for review of audit plans and review of complex /
for cause audits within the portfolio and holds their team accountable
- 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
- 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
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.
- 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
- 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
How to Apply
Interested and qualified candidate should:
Click here to apply
Note: When the page opens, enter the Job Opening ID (1040351) in the Job ID Box, and click "Search"
Application Deadline 25th October, 2016.