GXP Compliance utilizing SAP’s toolset including SAP QM

Closed Posted 1 year ago Paid on delivery
Closed

This position is a key deployment role with responsibility for the successful implementation of GXP operational management of the global QC Operations enterprise systems portfolio (LIMS, LES, CDS etc.) with adherence to the highest level of global regulatory GxP and 21CFR11 compliance with strategic focus on defining and enabling the digital transformation to ensure future fit of purpose for the next generation labs.

The role partners with the business global implementation team to drive standardized, efficient & effective processes that integrates and automates people, process, and technology. This will enable accelerated scalable & sustainable technology and data intelligent lab environment leading to enhanced smart decision making through prescriptive and predictive insights.

Responsibilities

• Strategy & Influence: Works with domain senior leadership and makes contributions to develop strategy. Adapts and executes domain strategic plans.

• Process Improvement & Optimization: Drives opportunities to improve process and/or technology.

Qualifications

• Bachelor’s Degree or equivalent education and 10+ years of experience. Masters degree preferred.

• Must have experience working in the pharmaceutical/medical devices industry with the FDA, EMEA and preferably multiple additional regulatory agencies in other foreign countries.

• Experience managing teams of at least 10 people with a resource mix of managers, employees, matrixed teams, virtual teams, contractors and managed service providers.

• Subject matter expert in technology and/or business domain.

• Experience in technology operation, strategy, planning and implementation and/or relevant business domain preferred.

• Experience of implementing SAP projects is mandatory ideally SAP S/4

• Domain knowledge in Finance or Procurement is mandatory.

• 7+ years of experience as a successful Information Technology Temm using structured project management processes.

• Experience working in a GMP environment and delivering GxP system solutions

• Solid Understanding of System Development Life Cycle (SDLC) concepts and methodologies

• Demonstrated competency planning and tracking project schedules with clearly-defined critical paths

• Ability to manage mid-level, multifunctional projects across multiple global locations

• Proven ability to obtain results in a global, matrix environment

• Excellent oral and written communication skills, as well as presentation abilities

• Demonstrated success communicating across a variety of audiences, including business people and technologists (both up and down the organization)

• Exceptional listening, problem solving, negotiation, and facilitation skills

• Proven leadership abilities and emotional intelligence

• Demonstrated success handling initiatives of medium complexity and risk

• Lead technical or risk assessment exercises where needed that pertain to GXP

• Provides support in collaboration with Compliance Excellence on local self-inspections and GIA Audits where required using where possible SAP Solutions

• Bachelors degree in a Scientific or technical field

• 3-5 years of experience in Quality or a compliance role within the pharmaceutical /medical device industry

• Experience in Warehousing, Logistics or Distribution Operations preferred.

• Working knowledge of GMP and GDP regulations

• Ability to build trustful relationships, engage and influence stakeholders at all levels.

• Excellent analytical, organizational, and problem-solving skills

• Experience in at least 3 of the following

o SAP's Electronic Records and Signatures (ERES) functionality

o SAP's audit trail functionality

o SAP's Quality Management (QM)

o SAP's Electronic Batch Records (EBR)

SAP HANA SAP 4 Hana

Project ID: #36198400

About the project

Remote project Active 11 mos ago