L1 P&P Lead (Secondment / 6-9 months)

Pfizer•Collegeville, PA

2d•Hybrid

About The Position

Colleague will support the management of the GMP Policy and Procedures Level 1 process grouping within the Quality Systems framework from end to end and provide global support to the PGS network. The document lifecycle includes interpreting regulations and ensuring requirements are captured with Global SOP documents. This is achieved by partnering with Global Process Owners to ensure clarity and obtain input on drafts. The colleague will partner with Regulatory Intelligence to review emerging regulations and ensure revisions to impacted Policies and Procedures are completed in a timely manner and ensure compliance with regulatory requirements. The colleague will also partner with the Internal Audit, Data Integrity, and Inspection Management team and with Regulatory Quality Assurance (Level 2 audit) to understand internal audit and inspectional observations, CAPAs and trends to identify needed Policy and Procedure revisions. The colleague will participate on projects that drive process improvements within the Policy and Procedure team and across PGS. The individual will also participate in quality compliance network initiatives as needed, act as change agent and help drive a mindset of continuous improvement.

Requirements

Applicant must have a bachelor's degree with at least 5 years of experience; OR a master's degree with at least 3 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
GMP experience in the pharmaceutical or medical device industry, with preference for a diverse background.
Must have expertise in quality systems /quality operations.
Technical writing experience
Understanding of current industry trends within Quality Systems
Understanding of board of health requirements and ability to navigate the regulations
Demonstrates leadership by constructively engaging with and providing PGS stakeholders with the best fit document content
Excellent communication skills with the ability to build relationships, influence outcomes, and to deliver effective presentations to a variety of audiences
Ability to work within tight timeframes and respond to changing requirements
Demonstrated ability to interact effectively with all levels of management and colleagues
Displays critical thinking expertise, including qualitative/quantitative data to define and implement a strategic approach to developing risk-based content
Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment
Experience with Microsoft Tools (e.g., SharePoint, Excel, Word)
Fluent in English

Nice To Haves

Project management skills desired.

Responsibilities

Emerging regulation assessments for impact to global Quality Policies and Procedures
Supporting the Global Process Owner throughout the Document lifecycle for Quality Policy, Global SOPs and Work instructions, including: Identifying the need for revision, Authoring / Technical Writing, Continuous improvement loop, Socializing changes, gathering feedback and closing the loop on communication of changes, Comment Gathering / Reconciliation, Approval Support
Global Process Owner with global document deployment, training, and coaching.
Manage the Policy and Procedure document change lifecycle.
Revise/create Policy and Procedure documents, assess changes for compliance, accuracy, and completeness, and ensuring deliverables are realistic and timelines are met.
Review emerging regulations and audit observations and determine potential impact to Policy and Procedures.
Ensure needed revisions are completed according to timelines.
Metrics and KPIs
Develop training materials related to Quality Framework documents
Coach PGS sites / functions to ensure appropriate application of Global requirements
Participate on team projects focused on continuous improvement
Actively participate in Process-related Communities of Practice (CoPs)
Support other quality compliance initiatives in the PGS network as needed