Director - Quality Systems

POSITION SUMMARY

Responsible for management, maintenance and global quality system for all company services and product lines in both domestic and international markets. Reviews metrics of all quality system elements and drives continuous improvement projects and corrective and preventive actions as needed. Assists with due diligence activities related to acquisitions and assists with integration and harmonization as needed.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Leads development, implementation and oversees quality systems to support and ensure compliance with FDA regulations and international tissue & medical device regulations, and accreditation standards; includes cGMP and cGTP, state licenses and accrediting body standards (ISO, AATB, AABB)

• Oversees Document Control, Change Control, Record Control and Training.
• Oversees Administrative oversight of Master Control (e-QMS system) to ensure any changes made are thoroughly understood and implemented within the system in a compliant manner.
• Works with business stakeholders to identify areas for harmonization and efficiencies.

• Supports merger and acquisition activities by leading diligence efforts and subsequent integration projects relating to quality systems.
• Stays abreast of current US and international industry trends and new regulations in order to analyze and anticipate their impact on the organization

• Manages all quality data for the global business units and provides visibility to trends and/or deficiency where applicable.

• Leads and supports a corporate culture of quality and compliance by diligently mentoring and developing staff, through regularly communicating vision, priorities, and complex operational requirements to both direct reports and senior leadership
• Develops an in-depth understanding of existing processes, the needs of clients, and the needs of strategic partners in order to identify opportunities for process improvement and the tools necessary to both implement and measure plans of correction through direct engagement and analysis of data
• Leads projects in the quality and regulatory department to ensure timely completion.
  • Extracts, analyzes, and evaluates various types of data and provides data-driven recommendations to Executive Leadership.
  • Establishes or re-engineers processes to improve the operational efficiencies and minimizes technical difficulties. Quickly identifies solutions to problems and assures corrections are expeditiously implemented

Supervisory Responsibilities

This position manages all employees in the Quality Systems department.

KNOWLEDGE, SKILLS and ABILITIES

Education and/or Experience

• Bachelor’s Degree is a requirement. ASQ certification and some level of Six Sigma training strongly preferred.
• 6-8 years of related experience
• Experience in either Biologics or Medical Devices required; both strongly preferred
• Experience in private equity funded organization is preferred
• Experience leading external regulatory inspections and re-accreditation required

Language Skills

Ability to speak and write English; communicate effectively and professionally with employees, clients and external contacts; read and comprehend instructions; write reports and correspondence; and effectively present information in one-on-one and large/small group situations to clients and employees; respond to inquiries or complaints from clients and regulatory agencies; and effectively present information and respond to questions from management, the Board of Directors, clients, and the general public.

Mathematical Skills

Computational skills required to support essential duties and responsibilities including the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Reasoning Ability

Ability to analyze data, interpret a variety of instructions furnished in written or oral form, and solve problems involving several concrete variables in ever changing situations.

Computer Skills

Proficiency in MS Outlook, Word, Excel, and PowerPoint.

Other Skills and Abilities

Excellent attention to detail; interpretive skills; problem-solving skills, customer service skills; project management skills; ability to maintain confidentiality; strong interpersonal skills to interact with peers and management; follow-through, and proactive nature/ability to take initiative; excellent organizational skills; and ability to manage multiple tasks simultaneously.

WORK ENVIRONMENT/PHYSICAL DEMANDS/TRAVEL

Work Environment/Physical Demands

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers and phones. There are several laboratory facilities in the organization and the employee must be able to interact with employees in this environment. The noise level in the work environment is usually moderate. 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 sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel or crouch. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision. This role may cover multiple locations and will be required to travel to those domestic locations. Travel is anticipated to be less than 10% of the time.

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.