The Quality Assurance Director ensures that we are distributing products of the highest quality.

DUTIES AND ESSENTIAL FUNCTIONS

• Establishes and maintains a Quality Management System
• Ensures the site is in full compliance with regulatory and industry requirements and standards.
• Plans, coordinates, manages and/or facilitates internal and external audits/inspections and provides leadership during regulatory authority visits.
• Leads quality programs, continuous improvement efforts, and provides quality review, guidance and recommendations associated with all efforts at the site.
• Is responsible for ensuring that all planned and unplanned quality & compliance issues are addressed.
• Addresses worldwide GMP standards as a Legal Manufacturer with a direct responsibility for the US market and delegated responsibility for International markets including additional oversight responsibilities for failure investigations and Auditing and Supplier Management.
• Provides project support for key deliverables and partners with customer representatives for ensuring product portfolio is adhered to during production.
• Functions as the key leader in developing the quality operational strategy and execution plans for the site in global matrix management of other departments/functions that perform activities on behalf of the site for the alignment with the site operations leader and primary owner of the site quality plan.
• Exercises legal manufacturer compliance.
• Demonstrates forward thinking leadership that drives continuous proactive engagement of the QA team.
• Manages inspection readiness programs and activities for the site, ensuring an inspection ready state.
• Proactively assesses quality issues to determine impact to in the field and ensures they are addressed in a timely manner.
• Proactively engages with appropriate teams to secure the GMP certification of the site as well as those of critical suppliers.
• Recruits, retains, trains, develops, and leads the Quality talent in support of the Quality Management System, manufacturing, and the Business Unit strategy.
• Supports a strong culture of empowerment, accountability and inclusion and seeks to develop team capabilities as well as foster personal growth.

REQUIREMENTS

• Strong leadership skills with strategic problem-solving ability which results in solutions and risk-based decision making.
• Excellent organizational skills with proactive management of multiple tasks of varied complexity.
• Negotiation and strong persuasive abilities, diplomacy, and positive influencing abilities.
• Experience leading/facilitating internal and external audits and providing leading role support during regulatory authority inspections required.
• Ability to establish and maintain cooperative working relationships with internal and external partners required.
• Ability to take initiative and work independently while effectively managing timelines required.
• Ability to perform in fast paced environment and in stressful situations is required.
• Influence, shaping solutions, negotiation and consultative skills are required

EDUCATION REQUIRED

• Bachelor’s degree from four-year college or university plus 5 to 10 years related experience and/or training preferred

JOB SPECIFICS

• Full time

Job Type: Full-time

Pay: $80,000.00 - $110,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 10 hour shift

Ability to commute/relocate:

• Lindon, UT 84042: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 1 year (Preferred)

Work Location: One location