Quality & Regulatory (Q&R) Data Analytics Manager

The Opportunity:

Under limited direction, direct the activities for the quality organization for their respective facility. Manage, organize, oversee and ensure the objectives of the QA/QC function are implemented in line with Corporate, site quality and business goals. Develop, manage, and maintain the quality management system to meet applicable regulatory requirements (FDA CFRs, U.S, and international regulations) and international quality standards; ensure products meet customer quality expectations and requirements. Develop, monitor and manage approved departmental budget. Ensure timely closure of all non-conformances, failure investigation reports and corrective/preventive actions; develop strategies for continuous improvement

Responsible for leading the development and deployment of a data analytics program for the Avantor quality and regulatory organization. This individual will work with sites, global quality/regulatory, and IT to develop user requirements, establish system integrations to Snowflake/PowerBI, develop dashboards/reports, and maintain those dashboards/reports. This role is responsible for ensuring a cohesive analysis of quality/regulatory data from an array of systems and ensure that the data can be delivered to leadership, sites and end-users in a readily consumable format.

MAJOR JOB DUTIES AND RESPONSIBILITIES

• Lead the global quality and regulatory (Q&R) data analytics program to establish:
  • Data Analytics user requirements
  • System integration requirements
  • Dashboard designs
• Develop and deploy dashboards for quality and regulatory to monitor key metrics/KPIs
• Maintain dashboards and data connections for all Q&R dashboards
• Use data to advise senior leadership on how to improve business performance
• Lead data analytics workstream of any new Q&R system deployments
• Identify improvement opportunities
• Work with IT and other application owners as other applications become interfaced
• Collaborate with IT teams to improve data infrastructure, including selecting and implementing appropriate tools and technologies in addition.
• Stay updated on industry trends and best practices in data management, analytics, and technology to drive continuous improvement while ensuring relevance.
• Other duties as assigned.

QUALIFICATIONS (Education/Training, Experience and Certifications)

• Bachelor’s degree from four-year college or university strongly preferred; or equivalent combination of education and experience.
• 5+ years of experience related to Quality Assurance.
• 5+ years of experience with data analytics
• Strong proficiency in data management, operations and analysis
• Expertise in data modeling, data warehousing, ETL processes, and data governance principles.
• Experience with Snowflake, SQL, PowerBI required.

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

• Strong communication skills, both oral and written.
• Strong interpersonal, presentation, and project management skills
• Able to influence change without direct authority
• Ability to effectively communicate and influence at all levels across the organization
• Functional knowledge of Microsoft Outlook, Word, and Excel, (or equivalent).
• Strong understanding of basic Quality Assurance and Computer System principles associated with ISO 9001, ISO 13485, 21 CFR 820, 21 CFR Part 11 and Q7.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

Typically works in an office environment with adequate lighting and ventilation and a normal range of   temperature and noise level.

Work assignments are diversified.  Examples of past precedent are used to resolve work problems.  New alternatives may be developed to resolve problems.

A frequent volume of work and deadlines impose strain on routine basis.

Minimal physical effort is required.  Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

Although the associate primarily works in an office environment, while performing the duties of this job, the associate may be exposed to a production environment.  The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud.  While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.

Must be able to travel, including internationally.  Travel is generally 10-20% of the time.

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