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Senior Director of Quality Assurance Job

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Primary Location: Greenville, SC

Job Tile: Senior Director of Quality Assurance

Job Number: 2017-53320

Date Posted: 9-26-2017

Job Summary

The Senior Director of Quality Assurance is a strategic leadership position that ensures that all regulatory, compliance and customer obligations are met. This individual interprets regulations and establishes the regulatory expectations and the Standards of Evidence for documentation to support compliance to Good Manufacturing Practice regulations.

This individual is responsible for the management of approximately 68 Quality Assurance professionals at both the Anderson and Greenville facilities. This individual is responsible for Continuous Quality Improvement projects, the Product Quality Review program, Internal Audit program, Deviation and Change Management programs, and the Master Control System. The Senior Director of Quality Assurance is responsible for training and developing the Quality Systems staff including the Directors, Managers, Quality Engineer(s), the Internal Auditor, and the Supplier Quality Specialist(s) within their organization. The Senior Director of Quality Assurance is also responsible for the company CAPA system and maintaining / developing the departmental budget.

This individual will lead the management of all independent audits conducted at the Nutra Manufacturing facilities on behalf of 3rd Party Customers, regulatory agencies, including FDA and TGA. This individual will serve as primary contact and liaison for all 3rd Party customers to address Quality and Technical matters. This includes the review and alignment of Customer Quality Assurance Agreements with the Nutra Quality Management System.

This individual will serve on the Nutra Leadership Team and the Site Quality Council. This individual will participate as a leader on other strategic initiatives to support On-Time Delivery, Right First Time, Costing and Personnel Development initiatives.

Essential Duties and Responsibilities

STRATEGIC – THIS INDIVIDUAL DIRECTLY OVERSEES THESE STRATEGIC ACTIVITIES:

  • Drives new ideas and innovation and develops strategies and tactics with respect to the QA quality system function to promote process improvements through the analysis and communication of quality metrics to key internal and external stakeholders.
  • Facilitates implementation of robust quality assurance initiatives related to management review, risk management and the generation of documentation to support GMP compliance.
  • Efficiently manages and utilizes resources within the Quality Assurance organization to ensure that business needs are met to support key strategic initiatives including Right First Time, On-Time Delivery, Cost Reduction and Personnel Development (learning organization).
  • Negotiate Quality Assurance Agreements with 3rd Party Contract Customers to ensure alignment with compliance expectations and current regulatory standards for compliance.
  • Ownership of continuous quality improvement through management of the corrective action preventative action (CAPA) systems, master control, and the global external auditing.
  • Provides leadership, development, coaching, mentoring and support for direct reports; Responsible and accountable for hiring and performance management of direct reports; Anticipates and plans for human resource needs.
  • Individual will serve as a member of the Nutra Leadership Team and the Site Quality Council.

TACTICAL

  • Responsible for implementing and maintaining an efficient and effective Quality Management System at the Greenville manufacturing site
  • Develops and executes annual audit plans as required by 3rd Party Customers. Negotiates and defends, where applicable, current plant Standard Operating Procedures and compliance practices to all regulatory agencies and auditors as required. Provides corrective action and oversees modification of documentation to ensure robust CAPA has been implemented
  • Ensures the quality engineers (QEs) complete annual product reviews (APRs) as required to meet customer expectations and regulatory requirements. Oversees the review and approval of APRs and other technical reports for the site.
  • Develops and ensures adherence to departmental budget; Assures financial performance goals are met
  • Updates Quality Systems accordingly to maintain compliance with corporate policies and standards and continuously monitors the regulatory environment and facilitates changes to align with changing regulatory expectations.
  • Conduct strategic assessments (i.e., gap analysis) of quality metrics and compliance needs - Presents quarterly quality trend reports to management and oversees the execution of corrective and preventative actions based on analysis of data.
  • Authors, revises and performs maintenance and administration of departmental control documents (i.e., SOPs, Work Instructions, Position Papers, etc) as necessary.
  • Assures the management of GMP quality systems including product complaints, change control, document control, exception management and training
  • Follows through on Quality System records such as deviations, change management and corrective and preventative Actions. Demonstrates prudent judgment when deciding which records require escalation to upper management;
  • Reviews and approves deviation reports as generated by Operations and provides constructive feedback on the content of these reports to ensure GMP compliance. Applies risk management principles to all high risk GMP activities.

Conducts performance reviews; develops growth plans; interprets, implements and supports employee-related policies, procedures and programs; Assigns appropriate projects and tasks to direct staff to ensure their continuous development.

LEADERSHIP RESPONSIBILITES

  • Manage, motivate, retain and develop technical professionals (exempt and non-exempt degreed professionals) and facilitate the development of a learning organization in which higher levels of execution such as analysis, synthesis and evaluation become second nature. This includes a Quality Assurance staff of approximately 68 individuals, ranging from Directors, Managers, Quality Engineers and Quality Monitors.
  • Ability to negotiate Quality Management System Standards with 3rd Party Customers.
  • Ability to function effectively at both strategic and tactical levels as a high profile representative of GNC and Nutra Leadership Teams.
  • Proven leadership skills including the ability to coach, mentor, assess, evaluate, develop, motivate, and empower others.
  • Advanced change control and risk management skills to challenge the status quo and drive improvements.
  • Models and supports organization’s goals and values.
  • Leadership by example, “roll up the shirtsleeves” management style and work ethic.
  • High personal ethical standards.
  • Ability to manage multiple projects and meet deadlines; self-motivation and goal oriented.
  • Good oral and written communication skills in order to communicate effectively with cross functional team members and management. Must be a team player and possess good interpersonal skills.

Job Specifications

Required:

  • 20+ years quality related experience in a cGMP or regulated manufacturing industry with at least 10
  • years’ experience in Dietary Supplement GMPs across multiple dosage forms
  • 10+ years’ experience with International Regulatory Standards of the International Committee of Harmonization for Product Development, Quality Risk Management and Quality Management Systems as applied to different regulated industries
  • 10+ years in a management or supervisory role

Preferred:

  • 5+ years of applying DSHEA and NLEA Labeling Regulations as codified in 21 CFR Part 101
  • >3 years’ international quality regulatory experience

Required:

  • Four year degree in science, life science or related discipline

Qualifications:

  • Advanced understanding and expertise in 21 CFR Part 111 (Dietary Supplement GMPs) and equivalent international quality regulatory requirements for manufacture of regulated products.
  • Understanding of DSHEA and NLEA Labeling Regulations for Foods and Dietary Supplements.
  • Highly organized with strong written and verbal skills and ability to work with all employees at various levels.
  • Familiar with all aspects of Quality Management Systems, including but not limited to CAPA and investigation management.
  • Ability to deal with difficult situations and various departments with tact, professionalism, and discretion and make risk based decisions in a timely manner. Ability to negotiate compromised solutions when issues are cross-functional across many departments and risk management principles must be understood and applied.
  • Proficient in personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheets, graphics, etc.

Licenses Registrations

Licenses / Registrations:

  • None required. Regulatory Affairs and/or Certified Quality Manager Certifications would be a plus.

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to talk or hear and sit. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision.
  • Extended hours walking, standing, sitting and traveling. Occasional travel to suppliers or customers as necessary (<25%).

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The noise level in the work environment is usually moderate. Office, manufacturing and laboratory environments.

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