At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Associate Director Clinical QA, you will be trusted to provide input and assist in establishing the vision and strategic direction for Clinical R&D activities in the R&D, QA, GCP, GLP and Medical Safety Operations Groups at our Main Campus in Fort Worth, TX.
POSITION PURPOSE
- Provides input and assist in establishing the vision and strategic direction for Clinical R&D activities as part of the R&D QA GCP, GLP and Medical Safety Operations Group.
- Provides Clinical QA oversight to ensure that global Clinical Operations activities conducted by Alcon for its medical devices and pharmaceutical products are in compliance with applicable regulations, guidelines and/ or quality standards.
- Manages the Good Clinical Practice (GCP) audit program across all Alcon franchises to assure clinical related activities are conducted according to Alcon and quality standards and applicable regulations with high degree independence.
In this role, a typical day will include:
- Provides leadership and sound business ethics in the interpretation and implementation of global GxP compliance programs, computer system and/or software validation and related services and compliance training while ensuring Clinical QA independent assessments.
- Supports clinical research and development activities for all Alcon franchises and Technology Platforms to maximize standardization and compliance.
- Advises senior management of the need for corrective and preventive actions with a key advisory role in the development of action plans and monitoring of effectiveness of action plans as a result of internal and/or external Regulatory audits.
- Ensures senior management awareness of compliance issues impacting regulatory acceptability, by appropriately escalating as per quality risk management.
- Provides support to relevant functions on proper identification and escalation of quality related issues.
- Trends, interprets and presents compliance data and metrics according to worldwide legal and regulatory requirements and Alcon standards.
- Drives/facilitates projects in collaboration with stakeholders to evaluate and or implement quality/compliance improvement initiatives.
- Leads or support cross-functional teams to evaluate impact of process changes to systems and related processes, to research best practices, determine solutions and manage change.
- Develops unique approaches to promote and instill a culture of quality and compliance.
- Provides coaching, and aid in the development of RDQA Clinical staff and business partners.
- Provides consultation and education including, but not limited to interpretation of global regulations and guidelines such as GCP, US FDA EU MDR, ISO Standards, etc.
- Authors or reviews & approves documentation including but not limited to audit schedule, plans and reports, documents associated with regulatory submissions, notes to file, study protocols, document templates, plans and reports, and clinical evaluation documents.
- Leads and supports the investigation of deviations and other quality issues detected from any source e.g., monitoring and data management, trends, signals, etc.
- Provides guidance, review, and approval of associated deviations (NCI, CAPAs and Actions) and evaluates effectiveness.
- Provides R&D QA support to Supplier Evaluation Teams, and function as Clinical SME for service providers.
- Leads audit & inspection preparation, conduct and remediation as needed, for both national and local inspections (e.g., FDA, EMA, MHRA, TUV etc.).
- Contributes to cross-divisional activities including but not limited to FAA, FSCA and/or Market Actions/ Investigational Product Field Actions as assigned.
WHAT YOU'LL BRING TO ALCON:
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs).
- The ability to fluently read, write, understand, and communicate in English.
- 7 Years of Relevant Experience
- 5 Years of Demonstrated Leadership
- Work hours: Exempt
- Travel Requirements: up to 20% as needed.
- Relocation assistance: No
- Sponsorship available: No
PREFERRED QUALIFICATIONS:
- Bachelor’s degree in science or technology.
- QA work experience in a regulated Medical Device / Pharmaceutical Industry.
- Strong R&D experience and knowledge, with manufacturing experience desired.
- Proven personnel management experience.
- Advanced knowledge of ISO 14155/ 14971, 13485, ICH 6, Medical Device and Pharmaceutical EU and FDA 21 CFR 820 / 211 regulatory requirements.
- Highly proficient in MS Office.
- Highly proficient in data analytics, critical thinking, and decision making.
- Proven influencing and negotiating skillset.
- Ability to lead virtual teams and function in a matrix organization, with project management experience desired.
- Advocate for exceptional Quality and Compliance Standards - does not compromise on customer expectations and regulatory requirements.
HOW YOU CAN THRIVE AT ALCON:
- Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
- Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
