Total 3 Director/C-Level Quality Assurance / Control job vacancies in Fort Worth - Main

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.

Find Jobs for Employees

Find Jobs for Contingent Worker

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.

Job Details:

The Quality Director provides leadership and direction to the quality department.  Facilitates development, implementation, delivery and evaluation of services within the division through collaboration with the organization’s leaders, clinical/medical staff directors, and other management.  Assures achievement of goals and adherence to policies, procedures, and standards set forth by state, federal, and hospital regulatory agencies.  Creates an environment of innovation and creativity through transformational leadership.  This position helps to strategically improve services and develop measurable outcomes throughout all departments and personnel.

Minimum Required Qualifications

• Bachelor’s of Science in Nursing preferred, or Bachelor’s Degree in a related field.
• Advance Degree preferred.
• Maintains current and active status on all required training and education as outlined by corporate policy.
• Maintains valid licensure/certification/registration. 
• Current valid driver’s license.
• Three to five years management experience preferred.
• Five to seven years of experience in clinical practice, hospital operations, and quality roles is preferred.
• Training or education in performance improvement techniques preferred.

Benefits:

We are excited to offer an aggressive compensation and benefits package for qualifying positions, which includes:

• Competitive base pay

• Matching retirement programs

• Health, Dental and Vision plans

• Health Savings and Flexible Spending Accounts

• Employee discounts including car rental, cell-phone plans

• Employer-paid, Long-Term Disability, Life, and AD&D

• Paid time off (PTO)

• Education Assistance Program

• Employee Assistance Program

• Employee Referral Bonus Program

• Discounted cafeteria meals

• Paid Parental Leave

• Employee Service Recognition program  

• Voluntary plans including: Life, AD&D, Short-Term Disability, Critical Illness, Accident, Insurance, and Hospital Indemnity

Great River Health and its affiliates are Equal Opportunity employers.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.

Hello,

Thank you for your interest in career opportunities with the University of Mississippi Medical Center.  Please review the following instructions prior to submitting your job application:

• Provide all of your employment history, education, and licenses/certifications/registrations.  You will be unable to modify your application after you have submitted it.
• You must meet all of the job requirements at the time of submitting the application. 
• You can only apply one time to a job requisition. 
• Once you start the application process you cannot save your work. Please ensure you have all required attachment(s) available to complete your application before you begin the process.
• Applications must be submitted prior to the close of the recruitment. Once recruitment has closed, applications will no longer be accepted.

After you apply, we will review your qualifications and contact you if your application is among the most highly qualified. Due to the large volume of applications, we are unable to individually respond to all applicants. You may check the status of your application via your Candidate Profile.

Thank you,

Human Resources

Important Applications Instructions:

Please complete this application in entirety by providing all of your work experience, education and certifications/

license.  You will be unable to edit/add/change your application once it is submitted.

Job Requisition ID:

Job Category:

Organization:

Location/s:

Job Title:

Job Summary:

Education & Experience

Bachelor's degree in business, healthcare or related field plus five years' related compliance experience in a healthcare setting to include two years of supervisory experience. Certification in healthcare compliance, registered Health Information Administrator preferred.

CERTIFICATIONS, LICENSES OR REGISTRATION REQUIRED:  NA

Knowledge, Skills & Abilities

Advanced knowledge of medical billing, to include billing policies and procedures for federal payers; advanced knowledge of medical coding and coding guidelines, for both professional billing and facility/institutional billing; knowledge of federal and state rules, laws, regulations, policies/procedures, etc. that are applicable to healthcare; knowledge of accounting/business principles; verbal and written communication skills; possess the ability to speak in public settings/forums; analytical/critical thinking skills; ability to work independently and in a group setting; have knowledge about and be skilled in utilizing basic business software applications.

RESPONSIBILITIES

• Provide day-to-day management of assigned staff and providing direction to staff regarding audits, healthcare rules, laws and regulations .
• Coordinate and facilitate committee meeting, to include those compliance subcommittees that oversee compliance of the university health system.
• Stay abreast of federal and state rules, laws, regulations, policies/procedures, etc. that are applicable to healthcare, third-party billing policies/procedures to include specifically federal payers, and coding updates.
• Develops, implements, and maintains system-wide programs, policies and procedures to ensure compliance with federal and state rules, laws, regulations, policies/procedures, etc. that are applicable to healthcare.
• Develops and implements/presents training, as needed, to ensure institutional healthcare compliance.  This will include both group and individual training, as necessary.
• Investigates/reviews allegations of alleged compliance plan violations, as needed or directed.
• The duties listed are general in nature and are examples of the duties and responsibilities performed and are not meant to be construed as exclusive or all-inclusive. Management retains the right to add or change duties at any time.

Physical and Environmental Demands
Requires occasional working hours significantly beyond regularly scheduled hours, occasional travelling to offsite locations, occasional activities subject to significant volume changes of a seasonal/clinical nature, frequent work produced subject to precise measures of quantity and quality, occasional bending, occasional lifting and carrying up to 50 pounds, occasional crouching/stooping, occasional driving, occasional reaching, frequent sitting, frequent standing, frequent twisting, and frequent walking. (occasional-up to 20%, frequent-from 21% to 50%, constant-51% or more)

Time Type:

FLSA Designation/Job Exempt:

Pay Class:

FTE %:

Work Shift:

Benefits Eligibility:

Grant Funded:

Job Posting Date:

Job Closing Date (open until filled if no date specified):