Director, Quality Assurance Compliance

Fort Worth, Texas, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical DevicesIndustries

Requirements

Candidates must possess a Bachelor's Degree or equivalent years of directly related experience, with a minimum of 10 years of relevant experience and 6 years of demonstrated leadership. Fluency in English is required. Preferred qualifications include extensive experience with FDA inspections, supporting Pharma and Medical Device product manufacturing, familiarity with complex global regulatory requirements for manufacturing, and a background in Chemistry.

Responsibilities

The Director, Quality Assurance Compliance will ensure alignment with global regulatory expectations and internal quality standards, serving as a liaison with Contract Manufacturing Organizations (CMOs). This role involves leading complex investigations, particularly those related to chemistry and analytical methods, and overseeing the Quality Management System (QMS). Responsibilities include managing change control, deviations, and complaints, ensuring compliance with cGMP and ISO standards, championing continuous improvement initiatives, monitoring key quality metrics, navigating ambiguous situations, resolving conflicts, and collaborating with cross-functional teams like Manufacturing, Engineering, and Regulatory Affairs.

Skills

Quality Assurance

Compliance

Regulatory Affairs

FDA

EMA

ISO

cGMP

Contract Manufacturing Organizations (CMOs)

Investigations

Root Cause Analysis

CAPA

Quality Management System (QMS)

Change Control

Deviations

Complaints

Audit Readiness

Risk Management

Chemistry

Analytical Testing

Contamination Control

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees