Senior Quality Specialist

At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives.

Our broad product portfolio includes renowned brands like Garden of Life, Nature's Bounty, Vital Proteins, Orgain, Nuun, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more.

We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.

Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.

Position Summary :

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Responsible for the quality assurance oversight responsibilities for the document management system (DMS) for VOWST product and quality control activities.

This role is responsible for the management of DMS administration, deployment of associated process, monitoring and improving the effectiveness of the processes and systems.

This position will report into the Director of Quality.

Key Responsibilities :

Provides document control management, record issuance, retention, and archival at Waltham, MA site

Provide quality assurance guidance, support and reviews for activities related to VOWST product and programs, ensuring follow up activities are complete and in compliance with requirements.

• Provide quality assurance guidance and support over quality control activities, deviations, change control, OOS, SCARs, QS audits, and CAPAs.
• Other duties as assigned including providing support to other quality groups as needed.
• Facilitate the actions for product-related quality events

Assessment of risk and impact on product quality, root cause analysis, corrective and preventive actions to mitigate the root cause, and to ensure successful effectiveness checks of those actions.

• QA SME and support to ensure compliance is addressed on change controls.
• Provide QA support on VOWST product related internal CAPAs and CMO CAPAs, including inputs to CAPAs such as audit findings associated with the CMO.

Documentation Program

Coordinate and maintain the documentation program to ensure patient safety, product quality, and overall compliance. Including performance as system administration for DMS.

Manage the physical and electronic archive record program. Coordinate and support the creation, revision, distribution, issuance, and maintenance of controlled documentation.

Subject Matter Expert (SME) for the document program during regulatory agency inspections for Waltham, MA site. Supports control room / back room during regulatory agency inspections.

Drive improvements and operational excellence in all areas.

Process Improvements & External Benchmarking

Establish standard work practices and visual management; drive continuous improvement culture through audit of process and systems and instilling ownership and accountability.

Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.

Define, manage, and continuously improve the documentation program to ensure patient safety, product quality, and overall compliance.

Identify documentation and records management issues and trends for system, procedure, and training improvements. Identify and implement opportunities for process and system improvement and enhancement.

Collaboration

Lead quality and process improvement initiatives and project teams. Evaluate questions and issues received from end users, make decisions on appropriate follow-up steps based on established processes, procedures, and guidelines and escalate to management, as appropriate.

Create close working relationships with various departments and subject matter experts to enhance documentation efficacy.

Building synergies with broader Nestle Health Science companies and identify opportunities for improvement. Promote Global Quality Initiatives and Quality culture by supporting innovation, teamwork, and efficiency within the team and organization.

Support the definition of current state risks and impact assessment of the state of compliance and inspection readiness.

Facilitate corrective actions, including updating policies and procedures. Provide QA input into the communication plan that provides weekly / monthly / quarterly updates on the status of the CMO to appropriate levels of management.

Support established communication plan for issue escalation. Provide Quality support in the ongoing improvement of product.

Experience and Education Requirements :

• Bachelor of Science degree or equivalent experience in life sciences or engineering.
• Minimum 4+ years of Quality experience in the pharmaceutical or biotechnology industry.
• Demonstrated ability to effectively organize and execute tasks. Strong verbal and written communication (including presentation) and customer management skills.
• Advance knowledge and demonstrated experience with documentation programs including the management of records and end user support for DMS.
• Quality Control oversight a plus.
• Experience working collaboratively with CMOs (Contract Manufacturing Organizations) and CTLs (Contract Testing Labs) a plus.
• Experience working collaboratively with cross-functional teams and managing the relationships and expectations of several key stakeholders.

Requisition ID : 320954

It is our business imperative to remain a very inclusive workplace. The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment.

All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law.

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