Pfizer Hiring for SCESQ Digital System and Quality Process Lead at Mumbai, India Full Time

ROLE SUMMARY

Accountable as Global Super user for SCESQ (Designated Points of Contacts (DPOCs)) for Global Digital solutions and as Global Subject Matter Expert (SME) for key Quality process within SCESQ.

ROLE RESPONSIBILITIES

• Reports to the global Quality Systems Lead in SCESQ

• Provides leadership within SCESQ for the Global Key Quality process and represents SCESQ in PGS global initiatives

• Provides leadership within SCESQ as Global DPOC the Digital Solution and represents SCESQ in PGS global initiatives.

• As SCESQ global DPOC for Global Digital Solution and as Global SME for key Quality process in SCESQ:

• Sets global direction & goals related to the Digital Solution & key Quality process

• Understands and maximizes stakeholder needs

• Communicates clearly and proactively with SCESQ colleagues and key stakeholders on Digital Solution and/or key Quality process strategy and upcoming changes, improvement, remediation actions, and other critical activities

• Seeks to continuously improve Digital Solution and key Quality process in SCESQ

• Coordinates provision of data and documents for Digital System and/or key Quality process in preparation and during audits/inspections of SCESQ locationsor as requested by key stakeholders

• Ensures system validation documentation are accessible through the SCESQ Inspection Readiness Portal

• Provides leadership to seeks solutions to remediate Digital System and/or key Quality process issues through liaising with internal SCESQ users/SMEs/POCs, Above Site Quality, Pfizer Digital and other stakeholders

• Train & coaches SCESQ colleagues in utilizing Digital System and/or key Quality process as applicable

• In collaboration with the “Digital Comment Tool”owner, maintain and lead the improvement activities with key stakeholders within PGS and Pfizer Digital

• Coordinates updates to Master data in Digital Systems pertaining to SCESQ

• Represents SCESQ in User Council Meetings for Digital System to learn and share learnings with SCESQ colleagues

• Supports the SME to ensure user tools related to the Digital System (e.g. guidance, work instructions) are available and made current on SCESQ communication platform

• In collaboration with the SCESQ Digital System Handbook owner, maintains and ensures accuracy of the information

• Performs Administrative function as applicable including user access

• As primary SCESQ liaison with Pfizer Digital owner for deployments or upgrades:

• Collaborate closely SCESQ SMEs/POCs, Above Site Quality, Pfizer Digital and other stakeholders to provides impact assessment, defines user requirements and system testing prior to the deployment in SCESQ.

• Influences Pfizer Digital owner to makes sure that needs for SCESQ are accounted for and timely action.

• Support the deployment validation activities and deliverables e.g. change control, site acceptance letter

• Participates in Hyper Care system update including trouble shooting on issues for major system changes as applicable

• Escalates critical issues to the SCESQ LT

• As SCESQ global DPOC for SCESQ Owned Digital Systemsthe following are additional roles and responsibilities in addition to the above:

• Develops user requirements, business case and funding

• Responsible for design qualification and validation

• Liaises with Digital Partners

• Responsible for the project management of new system or system upgrade from the development until deployment and ensure the set timelines are met

• Together with Digital Partner develop training package

• Assesses impact to SOP

BASIC QUALIFICATIONS

• Minimally BA/BS Science, Engineering, or related technical discipline

• Minimally 10 years in Pharmaceutical quality roles

• Demonstrated personal leadership to lead global cross functional initiatives, programs

• Experience and has depth of knowledge in managing Quality Systems, Lot Disposition, Vendor/Supplier Management, Managing end to end vendor qualification in Supplier Management System (SMS) and SAP Digital Systems.

• Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.

• Strong negotiation, influencing, verbal, written communication & presentation skills

• Is diplomatic, clear & succinct in communication with internal and external stakeholders

• Self-motivator, proven ability to lead independently

• Strong project management, organizing and planning skills and a high sense of urgency.

• Demonstrated knowledge of US, European and global GMPs and compliance issues

• Advanced computer skills with enterprise systems such as SMS, SAP, QTS, Documentum platforms & reporting tools

• Proficient in English and other languages preferred

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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