Director, Quality Risk Management
Location
Collegeville, PA | United States
Job description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve The Director, Quality Risk Management will report to the Quality and EHS Risk Monitoring and Review Lead, within the Quality Systems and Operations Compliance (QSOC) group.
Role is responsible to define 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 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 the continuous improvement of the current 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.
Role is responsible for leading cross-functional activities and teams that sustain, control, and improve the QRM processes within their remit.Additionally, the role will provide expertise in the collation, analysis, visualization, and presentation of risk information to enable customers to understand and apply QRM principles through knowledge transfer. This will involve the development of a business case for a longer-term digital strategy to manage all risk data.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.
How You Will Achieve It - Strong contributor to the design and development of the strategy for the global deployment of a Proactive Quality Risk Management program including governance, communication, infrastructure requirements, deployment timeline, tool application, monitoring.
- Contributes innovative ideas for continuous improvement.
- 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 (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).
- Develop and execute a training strategy that is flexible based on the needs of the organization.
- May support the design and development of training materials (or facilitates 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.
- Leads 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 on future electronic solutions to support and manage QRM activities and data.
- Collaborates with the Business line Leadership as well as with partners outside of Quality for topics impacting our mission.
- Lead or actively drive integration of risk principles on transversal projects, as assigned.
- Support the development and generation of performance indicators to measure progress of implementation and effectiveness use of the QRM.
Qualifications Must-Have - Bachelor's degree in Engineering or science discipline or equivalent.
- 10+ years of quality assurance and/or business process experience in the medical device, biotech and/or pharmaceutical industry.
- Quality Risk Management and/or medical device risk management experience.
- Strong understanding and practical use of ICH, ISO, and cGMP regulations.
- Recent experience demonstrating the capability to strategize, collaborate and execute on the successful completion of process improvements at a global level.
- Strong collaboration and conflict management skills when working transversally across multiple Business Units to achieve global objectives.
- High level of energy and enthusiasm and ability to energize others.
- Proven critical thinking skills to be able to connect GxP requirements with business processes.
- Effective verbal and written communication skills, including presentation skills. Able to communicate effectively at all levels of a matrix organization, as well as teach and present new ideas with clarity and simplicity.
- Ability to influence Pfizer policies/positions in response to a changing regulatory landscape.
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 digital systems to manage data and reporting, experience using data to drive solutions to business challenges.
- A willingness to contribute within a learning environment by sharing knowledge and best practices across the organization.
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.
Non-Standard Work Schedule, Travel or Environment Requirements - 10-20% travel when required.
- Work Location Assignment:Flexible.
Other job details - Last day to apply: March 22, 2024.
- Relocation assistance: No.
The annual base salary for this position ranges from $149,200.00 to $248,600.00. 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.
Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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. This position requires permanent work authorization in the United States.
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