Senior Manager, Quality Risk Management

What You Will Achieve
TheSenior Manager, Quality Risk Management, will report to the Quality and EHS Risk Monitoring and Review Lead, within the Operations Compliance Readiness group.
Role is responsible to support the global strategy, development, implementation and maintenance of the PGS Quality Risk Management business process in accordance with industry expectations and regulatory requirements. The role will accomplish this by defining (and designing) harmonized and standardized practices targeted at anticipating and avoiding unacceptable risks, aligning risk categories and methodologies for communication and fostering an informed culture whereby proactive behaviors and motivations are championed.
In addition, the role will be responsible for:

• Becoming a QRM expert to support to the network for all activities related to QRM processes
• Providing expertise in developing risk tool frameworks for the collation, analysis, visualization and presentation of risk information to enable customers to understand and apply QRM principles through knowledge transfer.
• Supporting the enhanced Quality Risk Review process to ensure integration with both the Quality and EHS risk review and monitoring processes allowing for harmonized risk prioritization methodology and risk prioritization rules.
• Leading cross-functional activities and teams in deployment activities who are responsible to sustain, control, and improve the QRM processes within their remit.

How You Will Achieve It

• Contributes to the strategy and future design of a Proactive Quality Risk Management program including governance, communication, infrastructure requirements, deployment timeline, documentation requirements, tool application and monitoring
• Effectively collaborates and communicates at all levels to ensure local and global processes are well defined and opportunities for continual improvement are explored
• Maintains the group's standards and supporting documents in support of current Regulatory requirements (FDA, ISO, ICH) and industry expectations for Quality Risk Management
• Leads and/or participates in risk reviews with the business leaders, Supports the aggregation, analysis and interpretation of data from multiple internal and external sources; and reports patterns, insights and trends into business performance, facilitate decision making and identify opportunities for improvement.
• Risk expert who strategizes and creates new risk methodologies or customized risk tools for the quality management system as well as business/operational needs (e.g.: Contam Ctrl, risk profile, new facility design).
• Supports deliverables pertaining to the QRM training strategy (with internal and/or service providers) in support of risk tools such as Failure Mode and Effect Analysis (FMEA), Preliminary Hazards Analysis (PHA), Hazard Analysis and Critical Control Points (HACCP) and other customized risk tools. Provides training on these tools either remotely, in person or through the creation of e-learning modules
• Creates and publishes regularly occurring communication regarding risk related topics for community
• Member of the global Risk Community of Practice with the network focal points (Risk Champions) to share knowledge and best practices
• Facilitates critical, complex risk assessments, as needed
• Partner with digital team on future electronic solutions to support and manage QRM activities and data
• Effectively collaborates and communicates with the Business line Leadership as well as with partners outside of Quality to solicit topics impacting our mission
• Co-Lead or participate on transversal projects to support Global Quality initiatives in close collaboration with all operations and global functions, as assigned
• Support the development and generation of performance indicators to measure progress of implementation and effectiveness use of the QRM
• Actively supports regulatory inspections as needed

Qualifications
Must-Have

• Bachelor's degree in Engineering or science discipline or equivalent
• 7+ years of quality assurance and/or business process experience in the medical device, biotech and/or pharmaceutical industry
• Project Management experience involving proven capability to strategize, collaborate and execute on the successful completion of process improvements (med scale)
• Good understanding and practical use of ICH, ISO and cGMP regulations
• Proven critical thinking skills to be able to connect GxP requirements with business processes and understand potential impacts
• Strong collaboration skills and proven experience in working transversally across multiple BU's to achieve global objectives
• Effective leadership skills, including the ability to influence, identify and constructively address conflict for productive outcomes
• Able to communicate effectively with stakeholders at all levels of a matrix organization, as well as teach and present new ideas with clarity and simplicity
• Able to work in ambiguous situations to identify and resolve complex problems
• High level of energy and enthusiasm and ability to energize others
• 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.

Nice-to-Have

• Master's degree or equivalent.
• Experience with the use of Risk Management tools (FMEA, HACCP, process mapping, and root cause analysis tools)
• Knowledge of data and reporting systems, experience using data to drive decisions and provide solutions to business challenges
• Contributes to a learning environment by sharing knowledge and best practices within and across the organization

PHYSICAL/MENTAL REQUIREMENTS
Mental agility to handle a broad scope of different types of quality assurance work (e.g. data analysis, communication, often virtually, 1:1 and with larger groups). Ability to independently problem solve and make recommendations for solutions. Role is primarily office-sitting, standing, walking, and bending.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Standard 40-hour work week
• Willing to travel up to 25%

Other Information:

• Work Location Assignment: Flexible

The annual base salary for this position ranges from $113,900.00 to $189,700.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Global Operations