AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

The Quality Systems Business Lead-ERP role will partner with Global & Site Quality Leadership Teams and other stakeholders to create a plan to help each AGC BIOLOGICS Site to achieve our objectives related to our ERP implementation and help our employee’s transition faster and adopt to our new ERP system.

This role will help drive the adoption of a global ERP system by leading cross-site teams to drive harmonized GxP processes and personally construct IT System requirements and construct/execute testing scripts to be used in implementation.

The Quality Systems Business Lead-ERP will report to the Director of Enterprise Integration for project deliverables and matrix report to the VP, Corporate Quality. This position will require travel to our six sites throughout the phases of the implementation process.

PRINCIPAL RESPONSIBILITIES:

This role will leverage the Corporate Quality Team and associated Quality System Communities to remediate key misalignments across the Sites and/or update the Quality Policies to ensure consistent application of requirements.
Direct QMS/QA/QC activities for the Microsoft Dynamics 365 implementation project across all AGC BIOLOGICS locations.
Participate in the discovery and design workshops
Develop business requirements, design business processes, guide best practice process
Responsible for data management including support of the configuration, development and implementation of new D365 capabilities and solutions.
Collaborate with Program Management Office and site-level operational leaders to develop and implement aligned Quality operational reporting processes across multiple locations.
Document all technical processes, requirements, workflows and process diagrams.
Support the ERP initiatives in design, development and implementation of plans to translate
Quality functional objectives into technical business systems.
Execute IT system validation tasks.
Partners across Quality and business stakeholders/leaders across GxP areas to ensure models (e.g., process ownership), capabilities, systems, and processes that are fit-for-purpose, effective and sustainable across operational areas and quality
Ensure the design and implementation of the Microsoft D365 solution enables efficiency, ease of administration, visibility, and optimization of the QA/QC function.
Authoring or reviewing, work process documents (SOPs and Work Instructions).

KNOWLEDGE, SKILLS & ABILITIES:

Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence in multiple global locations
Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
Experience driving and leading organizational change in a dynamic environment
Strong project management and problem-solving skills
Ability to execute and make timely and independent judgment decisions while balancing multiple priorities in a fast paced, results-driven environment
Ability to work effectively in a team environment and across all organizational levels, where flexibility, collaboration, and adaptability are important
Ability to understand and analyze complex data, and the ability to translate information to socialize change impact with change interventions required
Excellent verbal, written, and interpersonal communication skills
Advanced Microsoft Office (Outlook, Excel, Word, PowerPoint, and SharePoint) skills
Ability to travel up to 25% of the time (domestic and international)

EDUCATION/EXPERIENCE:

S. in a Scientificand 6+ years of relevant work experience, or relevant comparable background
4+ years of experience in Quality Assurance in the Pharma or Biotech industry.
Knowledge of applicable GxP (and Electronic Records/ Electronic Signatures) industry regulations.
Equivalent education and experience may substitute for stated requirements

COMPENSATION RANGE:

$97,917 - $129,250 annually

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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Quality Systems Business Lead - ERP

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