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Director, Quality

Job ID

2014-19017

# of Openings

1

Job Location

US-NY-BOHEMIA

More information about this job:

Overview:

This position is responsible for development of overall approach to planning, execution and integration of activities to best suit the organization to ensure consumer safety, product quality in compliance with regulations while meeting business needs in the most efficient manner. This role will also set the goals and objectives for all associates residing at our sites in Northeastern USA, including manufacturing, packaging and warehousing locations.

The successful candidate provides leadership, direction, training and resources to support the activities of Quality Assurance and Laboratory Management while ensuring the effective integration of the goals and activities with all other functional areas are achieved in collaboration with the Quality organization.

Responsibilities:

As a member of the Global Quality (QLT) and in collaboration with the Commercial leadership team to the person in this position interprets and deploys quality processes and systems to meet contract manufacturing, private label and export business requirements into application for production manufacturing and key business partners in the NBTY organization.

 

  • Manages the hiring, staffing, training, mentoring, development and annual performance evaluations for all Quality associates in this region either directly or in collaboration with the hiring manager
  • Deploys Corporate product quality and safety requirements at all facilities in Northeastern USA.
  • Ensures all products meet NBTY Inc. safety and quality regulatory requirements for the intended distribution market
  • Develops Quality plans for sites in collaboration with business teams, site leadership teams and the QLT
  • Sets objectives for each Quality team in support of the business needs using S.M.A.R.T. goals and O.G.S.M. objective setting tools to deploy Quality plans for sites in collaboration with business teams goals.
  • Manages all regulatory inquires, audits and or situations at NBTY Inc. Northeastern USA operations in collaboration with Corporate incident management team
  • Provides oversight of day-to-day departmental/staff activities (attendance, vacation, troubleshooting and problem-solving, etc.).
  • Review all product complaints reports and initiate/coordinate recall actions when required
  • Review and approve all non-conformances, deviations, and Out of Specification reports and provide recommendations and course of action.
  • Review all product complaints reports and initiate/coordinate recall actions when required.
  • Review and approved of all SOPs, standard testing methods, master manufacturing documents and product/raw material specification sheets.
  • Participate in or lead project teams including any/all of various internal functional areas/groups to coordinate the implementation of new and transferred projects (products, processes) to the facility, provide project plans that include approach rationale, document development, execution, and summary.
  • Communication with internal departments to ensure that each will follow though to meet agreed -to timelines, action items, etc. Prepares appropriate status information and communicates to executive level as required.
  • Assist in the planning, design, procurement of new equipment or physical systems where required, from a validation or industry compliance perspective.
  • Act as a liaison for all third party audits including customers and regulatory authorities. Act as liaison with customers with regards to customer’s validation and quality documentation requirements, approval of deviations and non-conformances.
  • Review and present validation related information to government agencies and to customers upon required by legislation and or customer contracts.

Experience:

  • Must have 7-10 years management experience, including multiple sites.
  • Food, pharmaceutical and or nutraceutical industry is required.

Education - Certification - Licenses & Registrations:

  • Bachelor’s in Pharmaceutical , Food Science, Chemical Engineering or Science related field required
  • Masters in science related field or Business Administration preferred

Skills:

  • Knowledge of cGMP and cGLP requirements for vitamin supplements and wellness products .
  • Experienced in ISO 10011 auditing requirements (preferably with auditing certificate, e.g. CQA or Lead Assessor)
  • Knowledge and application of ISO based quality management systems (FSSC 22000, ISO 9000, ISO 22000, etc.)
  • Management experience, including strategic planning and project planning, project management, and problem-solving skills
  • Excellent communication, strategic, tactical and interpersonal skills.
  • Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE etc.).
  • Knowledge in computer software programs (power point presentation, Microsoft office, statistics)
  • Experience in classroom training and adult education

Physical Demands:

  • Works in multiple locations with teams in factories in the region
  • Hours require 24/7 availability, travel approximately 60 – 80 % required
  • As Quality leader for the region this role requires flexibility with respect to work hours

About Us :

NBTY is a leading global vertically integrated manufacturer, marketer and distributor of a broad line of high-quality, value-priced nutritional supplements in the United States and throughout the world. Under a number of NBTY and third party brands, the Company offers over 22,000 products, including products marketed by the Company’s Nature's Bounty®, Vitamin World®, Puritan's Pride®, Holland & Barrett®, Rexall®, Sundown®, MET-Rx®, Worldwide Sport Nutrition®, American Health®, GNC (UK)®, DeTuinen®, LeNaturiste™, SISU®, Solgar®, Good 'n' Natural®, Home Health™, Julian Graves, Ester-C® and Natural Wealth brands.

NBTY offers a competitive salary and a comprehensive benefits package, which includes tuition reimbursement, health and dental plans, voluntary short-term and long-term disability, daycare subsidy and 401(k).

NBTY is an equal opportunity employer.

Please contact Human Resources at 631-244-2120 if you should need a reasonable accommodation to submit your information for our on-line job postings.

 

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