Job description

Director of Quality

SUMMARY

Responsible for leading the Quality Control and Quality Assurance functions and ensures the development, maintenance and effective implementation of all necessary Quality Systems, to achieve compliance regarding regulatory, quality and customer-related requirements.

Assures appropriate maintenance of all batch-related documentation and release of finished product for distribution; appropriate maintenance of SOP’s; customer complaint responses, with proposed corrective action(s), as needed. Assures inspection and appropriate disposition of all incoming components and raw materials, prior to use in the manufacturing process, as well as the performance of all in-process tests and inspections throughout the manufacturing process.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Applies cGMP principles in all areas of responsibility.
• Develops, maintains and implements effective Quality Systems that will enhance the company’s ability to ensure that all products and processes meet quality specifications and standards.
• Provides leadership and guidance in promoting and enforcing company quality policies and requirements.
• Assures company-wide QA training sessions for cGMP’s, SOP’s, company requirements, etc. and ensures that QC Inspectors follow appropriate inspection procedures and techniques.
• Oversees internal non-conformances and external customer complaints, in an effort to resolve them in a timely manner and that effective corrective / preventive actions are implemented, when deemed necessary.
• Assures that issues potentially affecting product quality / compliance are brought to the attention of Sr. Management and are assessed appropriately.
• Interacts with Operations Management and functions, as a resource to resolve quality issues.
• Hosts customer and regulatory audits and develops responses to audit observations.

QUALIFICATIONS

EDUCATION / EXPERIENCE:

• Minimum Bachelor of Science degree.
• Ten or more years of Quality Assurance experience in a regulated industry in a Management (Manager or Director) position.

SKILLS / ABILITIES:

• Thorough knowledge of cGMP’s.
• Ability to read, analyze and interpret technical procedures and government regulations; ability to write reports and customer correspondences.
• Proficiency with computer and Microsoft Office (Outlook, Word, Excel).
• Self-directed and able to work well independently, as well as in a team environment.
• Excellent reasoning, problem-solving and math skills.
• Exemplary leadership ability, to effectively articulate quality related issues to all levels of personnel.
• Excellent organizational skills as well as written and oral communication skills.

BENEFITS:

• Comprehensive Benefits Package, including 401(k).
• Compensation commensurate with relevant experience

We are an equal opportunity employer. Women, minorities, veterans, and individuals with disabilities are encouraged to apply.

Job Type: Full-time, On-site