Quality Director

Role Overview:

The Quality Director with GTI is responsible for the strategic planning, implementation, execution and sustainment of all quality initiatives for the Company. Operations span across several facilities in different states, supporting various fabrication as well as assembly and integration projects. This role will partner closely with other Company leadership members and department heads to develop and align the initiatives of the Quality department with Company objectives.

Job Responsibilities:

• Ensures that internal and external quality assurance procedures adequately evaluate products and processes, including submissions to regulatory authorities; develops and implements required modifications.
• Establishes and monitors vendor compliance program; develops and implements audits of external raw material vendors, contractors, collaborators, and other relevant organizations as needed.
• Plans, organizes, executes, and reports on all vendor quality-related activities; assures that vendors adhere to quality requirements and that a quality system is maintained.
• Develops and manages GLP, cGMP, GCP, and internal audits on products, stability programs, complaints, and related systems.
• Documents audit observations and recommends corrective actions as needed.
• Creates and maintains quality assurance databases, reports, and files; oversees preparation of audit reports.
• Coordinates with development, project management, regulatory affairs, and other appropriate departments to create systems that ensure integrity and quality of submitted data.
• Maintains current knowledge of government and industry compliance standards.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
• Collaborates with research and development during new product start-ups and product development; establishes key checkpoints for new products and processes; manages QA release of products for distribution.
• Reviews and approves completed batch records.
• Identifies and investigates in-house quality issues.
• Develops and maintains auditing schedules and budgets.
• Hires, trains, supervises, motivates, and develops quality assurance staff; manages schedules and workflow.
• Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.
• Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.
• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Performs other related duties as assigned by management.

Required Qualifications:

• At least 7 years’ experience in a Quality Director position, directly responsible for the quality initiatives for a Company. Preferred experience developing such initiatives for new facilities and supporting new production lines.
• Bachelor’s Degree in related field of work. Master's Degree preferred.
• Strong understanding of quality assurance and quality control, with experience in ISO audits.
• Proficiency with QMS platforms, including the implementation of such platforms.
• Demonstrated proficiency in supervising and motivating direct reports, as well as contractors.
• Excellent written and oral communication skills
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Proficient with Microsoft Office Programs.
• Proven leadership and business acumen skills
• Proven ability to handle multiple projects and meet deadlines
• Ability to understand any and all safety requirements and cautions
• Ability to perform the physical labor necessary
• Bilingual skills a plus.
• Ability to effectively communicate with people at all levels and from various backgrounds.