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Regional Director – Quality - Southeast & West Coast - Boca Raton, FL

 

Job ID 

2014-21140

# of Openings 

1

Job Location 

US-FL-BOCA RATON

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 the region, 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.

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.

 

Responsibilities:

  • 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 the Western 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. Western 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. 

(Note: these responsibilities are not all inclusive but cover the main responsibilities for the role.)

 

Reports:

5-6 Direct Reports: Total team is approximately 55-65 FTE, dependent upon the business needs to meet sales forecast requirements.

Qualifications, Experience, Education, Certification, Licenses & Registrations, Skills, Physical Demands:

  • Must have 7-10 years of  in the food, pharmaceutical and or nutraceutical industry
  • Proven experience in implementing and/ or improving quality systems
  • Management experience, including strategic planning and project planning, project management, and problem-solving skills
  • Experience in product/ formula development with focus on solid dose (R&D background)
  • Experienced lead auditor in HACCP and cGMP's as per 21CFR part 110 and 111 or 210 and 211
  • Proven experience in building and developing teams
  • 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 of quality management systems (FSSC 22000, SQF etc...)

·         Management experience, including strategic planning and project planning, project management

·         Excellent communication, strategic, tactical and interpersonal skills.

·         Knowledge in computer software programs (power point presentation, Microsoft office, SPC software)

·         Excellent communication, strategic, tactical and interpersonal skills.

·         Excellent soft management skills

·         Ability to create strategic plans and drive the execution

·         Team builder and excellent coach

·         Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, process capability, value stream mapping multi-variant DOE etc.)

·         Bachelor’s in Pharmaceutical , Food Science, Chemical Engineering or Science related field required

·         Masters in science related field or Business Administration preferred

·         Works in multiple locations with teams in factories in the region

·         Hours require 24/7 availability, travel approximately 30 - 40% required

·         As Quality leader for the region this role requires flexibility with respect to work hours 

 

 

NBTY is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 

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.

 

Apply Now

 

 

 

 

 

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