Director of Quality at Precision Science Inc – Phoenix, Arizona

Precision Science is seeking a Director of Quality for our north Phoenix facility located at 1517 W. Knudsen Drive Phoenix, AZ 85027. This a full time position and comes with the following great benefits:

• Affordable medical, dental, vision, life and disability after the 1st of the month
• 401k match program
• 10 PAID HOLIDAYS
• Paid Time Off and Paid Sick Time
• Career Development Opportunities

SUMMARY OF POSITION:
The Director of QA/QC will provide day-to-day management of Quality Assurance (QA), Quality Control (QC), and regulatory compliance functions, including oversight of QA, QC, and compliance initiatives. Work with functional groups to provide direction and appropriate solutions for compliant operational practices. Drive decision-making and issue resolution on QA, QC and compliance matters. Advise management on areas of regulatory / business risks related to compliance activities.

KEY DUTIES OF RESPONSIBILITIES:
Lead the site Quality Management System, covering QA, QC lab operations, document control, Standard Operating Procedures (SOPs), training, deviation management, investigations, CAPA, change control, complaints, internal audits, stability and validation programs, and management review.
Oversee quality and disposition of raw materials, packaging, in-process and finished products, and stability programs; authorize stopping production or release for quality, safety, or compliance issues.
Manage QC lab operations, including testing, method lifecycle, investigations, reference standards, sample retention, and data integrity.
Lead inspection readiness and act as main quality contact during regulatory and customer inspections.
Make batch disposition decisions and escalate as needed for quality or safety concerns.
Supervise supplier quality, contractor qualification, quality agreements, and audit activities.
Collaborate with Account Management, Operations, Development, Maintenance & Engineering, and Supply Chain for product transfers, validation, improvements, and scale-up.
Set and track site quality metrics; drive improvements in deviations, CAPA, complaints, OOS rates, audits, and lab turnaround.
Build team capability through hiring, coaching, structuring, succession, and performance management.

The above statements are intended to describe the general nature and level of work being performed by employees in this position. This is not intended to be an exhaustive list of all responsibilities.

QUALIFICATIONS:
Over ten (10) years of progressive quality leadership in pharmaceutical, animal
health, veterinary, supplement, or other regulated manufacturing sectors.
Comprehensive knowledge of Good Manufacturing Practice (GMP), Good
Documentation Practice (GDP), and applicable Food and Drug Administration
(FDA), Environmental Protection Agency (EPA) and Drug Enforcement
Administration (DEA) regulations governing animal food and drug products,
including 7 CFR 250 and 21 CFR Parts 210/211, 225/226, 507, as well as
supplementary regulations (such as NASC, APHIS) relevant to the industry.
Proven experience managing FDA and governmental inspections, customer audits, and demonstrating consistent readiness for regulatory inspection.
Demonstrated capability in administering quality systems including batch disposition
and release, complaint and nonconformance investigations, Corrective and
Preventive Action (CAPA), calibration, change control, and laboratory compliance.
Experience with technology transfer and method transfers. Comprehensive knowledge of equipment qualifications and process validations.
Prior experience in an animal food contract manufacturing Contract Development and Manufacturing Organization (CDMO) environment is highly desirable.
Knowledge of animal health, veterinary products, or EPA-regulated products is preferred.

EDUCATION / TECHNOLOGY SKILLS:
Requires a bachelor’s or master’s degree in scientific discipline.
Professional certification in quality, compliance, or regulatory affairs is a plus.
Proficiency with MS Office, quality system databases, and electronic document
management.

PHYSICAL REQUIREMENTS:
May be required to work in the summer, winter seasons and in an environment that handles raw materials such as wheat, alfalfa, soy or peanut butter.
Prolonged periods sitting at a desk and working on a computer.
Must be able to lift up to 25 kilograms at times.

Precision Science is An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, genetic information, or protected veteran status.