• Support tracking, reporting and driving closure of Quality Records (e.g. NOE-Notice of Event, CC – change controls, CAPA – corrective action preventative action)

• Mentor quality record owners and complete compliance review where applicable to ensure quality records are submitted RFT (Right First Time)

• Run the Audit Ready 365 programme and work with the teams to plan, coordinate and track coaching sessions

• Support internal and regulatory audits coordinating requests for the QA Validation team

• Drive Quality and Compliance in our Validation activities by aligning practices as they relate to Compliance, Audit Readiness and Training for IOPS QA Validation

• Collaboratively identify improvements across both sites

• Develop processes and systems that drive compliance to critical regulatory requirements.

• Development and deployment of Validation specific training.

• Influence the development and revision of local and global policies, standards, procedures and business processes in alignment with industry standards and best practices for Validation.

• Generation of validation project deliverables and schedule, including integration of deliverables/schedule into larger project team plan.

• Evaluates breakthrough achievement versus schedule plan, and translates information to reportable metrics.

• Formulates efficiency improvement to ensure timeliness of validation deliverables.

• Ability to concisely deliver project reports to management.

• Generates implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

• May prepare equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs. Analyzes the results of testing and settles acceptability of results against pre-determined criteria.

• Investigates and troubleshoots problems which occur and resolves solutions or recommendations for changes and/or improvements.

• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

• Reviews, edits and approves change control and SOPs.

• Collaborates with functional departments to resolve issues.

• May directly supervise contingent workers.

• Provides direction and assigns work to full time employees and contingent workers to meet goals and deadlines. Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• Lead and drives projects and programs.

• Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. SIP Qualification, Cleaning Validation, Lab Equipment Qualification, Cleanroom Qualification)

• Must be able to present in a “pressure test” scenario the technical area that they are SME for

• Ensures that all quality-based deliverables are following regulatory and quality policies and procedures and timelines are met and observations are corrected.

• May present at both internal and external (regulatory) audits

• Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends.

This role may be a fit for you if you:

• Maintain integrity and honesty at all times

• Are able to work independently or as part of a team

• Are able to communicate with transparency

• Continuously aim to improve processes for improved performance

• Run internal and external relationships

• Develop strategy and create metrics to measure effectiveness of strategy

• Translate ambiguity into actionable steps

• May lead others through influence rather than direct authority

• Ability to resolve conflicts and coach others on problem solving

• Identify and effectively communicate risks

To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences and the following minimum amounts of relevant experience for each level:

• Associate Project Manager QA Validation: 8 years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.