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Facility Quality Manager (Sudbury, MA)

Nestle
United States, Massachusetts, Sudbury
February 20, 2024

As a leader in the science of nutrition, Nestle Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life, Nature's Bounty, Vital Proteins, Nuun, Persona Nutrition, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

We have more than 11,000 employees around the world, and products available in over 140 countries.

This position is not eligible for Visa Sponsorship.

Job Description:

The Facility Quality Manager will be responsible for ensuring the compliance of the quality systems, manufacturing processes and associated records for adherence to Nestle Health Science. This role will help to ensure that the Standard Operating Procedures (SOP's) and Good Manufacturing Practices (cGMP's) are in effect within their manufacturing site, assuring the quality of products produced. This is a People Leader role that will work onsite Monday to Friday at Nestle Health Science's manufacturing site located in Sudbury, Massachusetts.

Responsibilities:

* Develops staff through feedback, coaching, counseling and support.
* Ensures both new and existing associates are trained on cGMPs as it relates to 21 CFR part 111.
* Maintains compliance with FDA Regulations and other industry accepted standards.
* Supports and participates in audit preparations and inspections by certifying agencies and regulatory bodies, i.e. USP & FDA. Participate in developing action plans and executing corrective actions in a timely manner.
* Leads, anticipates, assesses and manages current and future compliance in the facility.
* Ensures accurate and timely completion of all tasks relating to Batch records and maintenance of cGMP and SOP records.
* Leads and/or supports investigations through Root Cause Analysis and effective Corrective and Preventive Action (CAPA).
* Evaluate data using statistical tools. Lead or actively support Product Change Control.
* Works collaboratively with cross-functional teams to implement necessary production changes, system updates, and documentation revisions in a timely and productive manner.
* Facilitates and properly manages the oracle based PQM (Product Quality Management) including but not limited to; Deviations, Non-Conformances, CAPAs, Change controls.
* Actively participates in current Nestle integration activities for Quality Systems, Quality Standards and SAP implementation.
* Facilitates and presents data and information pertaining to quality performance to upper management.
* Facilitates Material Review Board (MRB) for non-conforming materials, determination and documentation of dispositions of said material.
* Develops cross functional and multinational relationships to support interaction with various internal customers.
* Supports, leads, administers all mock recall activities for the site; is the expert in the area of mock recall, retrieval, and recall.
* Demonstrates leadership through a commitment to communication, work habits and be fully competent in all aspects of a wide variety of processes including maintaining safety, troubleshooting/problem solving, decision making, organizing/planning, Nestle core behaviors, administrative, quality appraisals, sampling plans, manufacturing audits/process audits, statistical techniques, production control systems, manufacturing document review, test equipment and training.
* Partners with Operations team and Technical Services group to execute and facilitate site initiatives in pursuit of business objectives and targets.
* Acts as role model of the business vision and mission and have a strong understanding of what it takes to achieve company goals, KPI's and metrics.
* Supports continuous improvement activities when Quality KPIs are not met.
* Supports management of the HACCP Program for the facility.
* Support goal setting, administers performance appraisals and conducts interviews for new candidates.
* Responsible of supporting HPS (High Performance Systems) principles and beliefs.
* Performs additional duties and tasks as assigned by the Senior Director of Quality.

Requirements:

* Bachelor's degree in Science, Food Science, Engineering or in a related field required; Master's degree preferred.
* 7+ years of Quality experience within the Food, Dietary Supplement, Medical Device or the Pharmaceutical industry required.
* Experience in VMHS (Vitamins Minerals Herbals Supplements), Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field required.
* 2+ years of experience managing and leading teams as a People Leader.
* Demonstrated fluency in MS Office (Word/Excel/Outlook/PowerPoint) required.
* Knowledge of FDA regulations for the cGMP of Dietary Supplements and Foods required.
* Experience with Food Safety plans/HACCP, GFSI required.
* Must have excellent communication (oral and written), organizational, teamwork and stakeholder management skills (ability to build cross-functional stakeholder partnerships).
* Must be detail oriented, with a proven ability to manage Quality systems and processes.
* Ability to lead, train, motivate, and work within a team
* Knowledge of Quality Management Systems e.g. CAPA, Product defense, Pest Control required.
* Knowledge of auditing techniques and quality toolkit - problem solving, basic statistics, investigations, corrective/ preventive actions required.
* Willing and able to work under pressure to meet tight deadlines with minimal supervision.
* Knowledge of regulatory and GMP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred.
* SQF practitioner / FSSC/ BRC/ ISO experience preferred.
* AS400 Knowledge is highly desired.

* Current or prior experience with SAP a plus.
* Willing and able to travel up to 5% based on the needs of the team and the business.

Requisition ID:
272688

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestle. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestle seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestle home.

The Nestle 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. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.

This position is not eligible for Visa Sponsorship.

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