QSEO Transformation Program Lead (Secondment - 24 Months)

Pfizer•New York City, NY

21d•Remote

About The Position

The QSEO Transformation Program Lead provides oversight, leadership and strategic direction for developing and deploying foundational programs that are critical to operations and quality . This role reports to the VP, QSEO Transformation and is focused on the development of programs that will enable certification of colleagues in key disciplines across the QMS including technical capabilities for each technology platform. Additionally, a sustainable internal training capability for this program will also be established. This role is a horizontal integrator working across the key PGS functions, Operating Units and more broadly within Pfizer and with external partners/stakeholders, as needed. Develops and deploys a program or programs that will deliver a simplified and standardized platform for sustainable risk-based quality decision-making including but not limited to. Critical QMS elements i.e. disposition, non-conformance management, change management, risk management. Aseptic programs such as colleague training and entry qualification, observation & coaching, contamination control strategies, Annex I assessment and remediation. Technical modules to support other technology platforms i.e. API, SOD, LMDS. Program(s) will yield colleague certification in key disciplines and establish train the trainer capabilities to sustain the program(s) using internal as well as external resources. Partners with the Global Process Owners, Process Leads and key subject matter experts in evaluating, developing and implementing innovative programs to stay current with evolving regulatory expectations and industry trends. Maintains industry knowledge to influence internal and external industry practices to deliver a simplified and standardized model for sustainable risk-based quality decision-making. Collaborate with peers, Operating Unit and Operating Unit Quality Leaders to review metrics and identify necessary enhancements and initiatives. Supports site-specific remediation activities as needed. Remains current with regard to regulatory expectations, updates to guidance and published regulations. Leads or supports key projects/initiatives within this initiative scope. Coaches and develops network SMEs to drive colleague growth and performance. Coordinates and evaluates internal / external benchmarking. Assesses long-term strategy for PGS network to ensure Pfizer is industry leading.

Requirements

BA/BS 12+ years, MBA/MS 10+ years, PhD or JD 7+ years or, MD/DVM 5+ years.
15+ years in a technical/leadership role in the biopharmaceutical manufacturing or related areas.
Experience leading the development and technical growth of colleagues to support business transformation.
Strong strategic skills with experience in solving complex and unique problems that drive improvements on a global basis.
Strong knowledge of quality and manufacturing operations with a focus on key skills and capabilities in decision-making specifically risk-based quality decisions.
Experience in leading/influencing internal and external stakeholders.
Experience in managing projects that require critical thinking, collaborative approaches; innovation; strong analytical skills; ability to understand business/quality issues and processes
Candidate has 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.
Understanding of both the technical and global regulatory expectations around Large and Small Molecule operations including technical manufacturing requirements across the platforms.
Proven leadership skills and demonstrated ability to drive organizational change and continuous improvement.
Experience working with complex organizations, with demonstrated excellence in developing and managing effective teams, and working across multiple cultures.
The candidate must be self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.
Knowledge of Integrated Manufacturing Excellence (IMEx) or other lean manufacturing approaches.

Nice To Haves

An advanced degree is preferred.
Detailed knowledge of Aseptic Operations or other technology platforms.
Ability to create and implement innovative solutions that cater to future business needs.
Extensive professional networks and an established reputation within the external market access sphere.
Strong strategic mindset, with a deep understanding of market needs and resource allocation.
Ability to assess competitive intelligence to inform the strategy for specific technology areas.
Strong interpersonal skills, fostering a culture of ownership, leadership, and management excellence.
Ability to gown to enter manufacturing areas.
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.

Responsibilities

Develops and deploys a program or programs that will deliver a simplified and standardized platform for sustainable risk-based quality decision-making including but not limited to. Critical QMS elements i.e. disposition, non-conformance management, change management, risk management. Aseptic programs such as colleague training and entry qualification, observation & coaching, contamination control strategies, Annex I assessment and remediation. Technical modules to support other technology platforms i.e. API, SOD, LMDS.
Partners with the Global Process Owners, Process Leads and key subject matter experts in evaluating, developing and implementing innovative programs to stay current with evolving regulatory expectations and industry trends.
Maintains industry knowledge to influence internal and external industry practices to deliver a simplified and standardized model for sustainable risk-based quality decision-making.
Collaborate with peers, Operating Unit and Operating Unit Quality Leaders to review metrics and identify necessary enhancements and initiatives.
Supports site-specific remediation activities as needed.
Remains current with regard to regulatory expectations, updates to guidance and published regulations.
Leads or supports key projects/initiatives within this initiative scope.
Coaches and develops network SMEs to drive colleague growth and performance.
Coordinates and evaluates internal / external benchmarking.
Assesses long-term strategy for PGS network to ensure Pfizer is industry leading.