Senior Manager - Clinical Quality Assurance

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 SENIOR MANAGER - CLINICAL QUALITY ASSURANCE , supporting our QA GOOD CLINICAL PRACTICES TEAM , you will be trusted with Good Clinical Practices (GCP) (Life Sciences) work ensuring implementation of quality plan at every stage of the Clinical Trial process / operations at the FORT WORTH MAIN in FORT WORTH, TEXAS, US.

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 (with high school diploma 15 yrs; with Assoc. degree 11 yrs; M.S. 4yrs; 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 : Monday through Friday – 8 : 00am – 5 : 00pm

Travel Requirements : 0 to 20%

Relocation assistance :  No

Sponsorship available : No

PREFERRED EXPERIENCE :

2 to 3 year (s) Strong clinical background in Ophthalmology or Optometry

Experience 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 :

Collaborate with teammates to share standard processes and learnings as work evolve

See your career like never before with focused growth and development opportunities

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 for exempt associates, PTO for hourly associates, and much more!