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 QMS, QA Compliance/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 achieve the quality and compliance objectives related to the ERP implementation and help our employee’s transition faster and adopt to the new ERP system. 

This role will lead the adoption of standardize/harmonized GxP processes and have overall responsibility for strategic direction and oversight of processes, systems, and governance across GxP controlled procedural documents (e.g., Standard Operating Procedures, Work Instructions) and GxP training and education.

This role will have leadership responsibility for evolving our GxP Controlled Documents and Training capabilities and operations for sustainability and effectiveness supporting AGC Biologics growth and expansion across all sites

Ability to balance both long and short-term objectives, as well as to effectively engage GxP business stakeholders for value-added impact and change management, will be key to success in this role.

This individual will ensure organizational capabilities in deployment of progressive, effective and fit-for-purpose Controlled Documents and Training models across GxP areas. This individual will also work with relevant areas/functions in evolving process ownership and establishing relevant measures of process health.

This individual will have a passion for quality by design and process simplification, a record of excellence in partnering with stakeholders at all levels for delivery of business-enabling processes and demonstrated team leadership, talent development and organizational performance. This individual will demonstrate AGC Biologics Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency.

The QA Compliance/Business Lead-ERP will report to the Director of Enterprise Integration for project deliverables and matrix report to the Global VP, QA and ideally be based in one of our US Sites or Copenhagen, Denmark. Travel to all sites required throughout the phases of the implementation process

PRINCIPAL RESPONSIBILITIES:

 

  • This role will need to use the Global QA Team to bust through misalignments across the Sites and/or update the Quality Policies to force the decision.
  • Provide frequent communication to all employees and tools to Site Management to cascade project information and ensure alignment in compliance decisions.
  • Manages resources to provide oversight of Data Integrity and Technology for GxP lifecycle activities and practices for AGC Biologics.
  • PROCESS MANAGEMENT: Actively engages across business areas in a collaborative manner for maturing standards, systems, and strategies for GxP process/procedures and training/education delivery in support of quality improvement, process ownership, and operational excellence. Actively champions and technically guides operating staff to translate strategy into results
  • ALIGNMENT/COLLABORATION: Engages the organization through direct line-of-sight of their work to AGC Biologics's V/S/M and QMS design, deployment, effectiveness, and continual improvement
  • ROLE MODELLING: Consistently demonstrates an ongoing commitment to achievement of AGC Biologics and Quality goals, as well as the success of all team members consistent with the AGC Biologics Leadership Model
  • Coordinate with IT on Computer Software Assurance (Validation) tasks.
  • Direct and lead all QA/QC activities for the Microsoft Dynamics 365 implementation project across all AGC BIOLOGICS locations.
  • As overall accountable Process Owner, provides strategic guidance and oversight to GxP Standards/Controlled Documents and Training processes and systems in ensuring effectiveness of model design, procedures, tools, templates, systems (e.g., GxP Controlled Document Management System, GxP Learning Management System), and training
  • 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
  • Function as the QA/QC SME (Subject Matter Expert) on the project core team and coordinate activities for support team members related to purchasing, planning & scheduling, warehousing & inventory management, manufacturing and various QA/QC GxP processes.
  • Ensure the design and implementation of the Microsoft D365 solution enables efficiency, ease of administration, visibility, and optimization of the QA/QC function.
  • Collaborate with the Director Business Integration and site-level operational leaders to develop and implement aligned SCM and operational reporting processes across multiple locations.
  • Partner with cross-discipline project team to leverage the D365 platform across the business.
  • Authoring, reviewing, and approving work process documents (SOPs and Work Instructions).

 

KNOWLEDGE, SKILLS & ABILITIES:

 

  • Broad and deep global health regulatory agency knowledge and experience across multiple GxPs with current knowledge of industry trends and best practices for quality, efficiency, compliance, and effectiveness
  • Broad and deep quality risk management, process management, project/program management and continuous improvement knowledge and experience
  • Demonstrated strategic planning and execution skills required
  • Proven ability to design/evolve and /or implement Quality Management Systems (e.g., Quality Standards, SOPs, Training, Quality Improvement) in a fit-for-purpose manner enabling effectiveness, flexibility, and adaptability in a dynamic and evolving business model
  • Current knowledge of industry trends and best practices for progressive quality management in a regulated environment
  • Developing individuals and teams; proven leadership capabilities within multi-level organization
  • Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
  • Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
  • Operational Excellence experience with proven ability to lead improvement Projects-Experience with Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
  • Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
  • Excellent communication and relationship building skills working with colleagues in multiple global locations
  • Experience driving and leading organizational change in a dynamic environment
  • Experience building partnerships, consulting, influencing, and negotiating with business executives, leadership, human resources partners, and peers to gain commitment and accomplish business goals
  • Strong project management and problem-solving skills
  • Ability to effectively assess and analyze stakeholder, partner, or client needs while consulting, building solutions, and developing processes
  • 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:

  • BS. in a Scientific, Computer Science, Information Management or allied health field (or equivalent degree) and 8+ years of relevant work experience, or relevant comparable background
  • 6 or more years of experience in Computerized Systems Quality Assurance and Data Integrity in the Pharma or Biotech industry.
  • Deep and broad knowledge of applicable GxP (and Electronic Records/ Electronic Signatures) industry regulations.

 

 

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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