L1 P&P Lead (Secondment - 12 months)

WHAT YOU WILL ACHIEVE

• 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.

HOW YOU WILL ACHIEVE IT

• 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

QUALIFICATIONS

Must-Have

• 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-Have

• Project management skills desired.

PHYSICAL/MENTAL REQUIREMENTS

N/A – Normal office environment and computer usage

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to work flexible hours to occasionally accommodate sites / colleagues in different time zones (e.g. evening or morning teleconferences)

Occasional travel to a PGS site for meeting, training, or assist site

OTHER JOB DETAILS

• Last Date to Apply for Job: December 16, 2025

• Additional Location Information: Any US Site / Any Europe Site

• Eligible for Relocation Package – NO

• Secondment 12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control