Auditor, Good Clinical Practices (GCP)

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, youll 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.

In this role as an Auditor, you will lead and conduct independent Good Clinical Practice (GCP) risk-based audits across all Alcon franchises to assure clinical related activities are conducted according to Alcon qua lity standards and applicable regulations. In this role, you are responsible to perform audit metrics and root-cause analyses of non-compliances and provide guidance, training and support to the business partners. Your a udit types include Investigator Sites, Vendors, Systems and Documents (i.e., regulatory submissions) and other audits as assigned.

JOB FUNCTIONS

Plans, conducts, and manages GCP (remote or onsite) and or other type of GXP audits with a under limited supervision.

• Supports and contributes to the overall audit planning and scheduling process. Ensures assigned audits are tracked appropriately. Submits audit plan change control documentation as needed.

• Ensures audit observations are communicated appropriately to Auditee and Senior Management. Ensures escalation process of critical observations is followed. Prepare and distribute audit reports according to Alco n requirements and timelines.

• Reviews, evaluates and approves proposed corrective and preventative action plans (CAPA) in collaboration with the responsible business partner .

• Provides guidance and advice to clinical teams on GCP related questions.

• Tracks, t rend s , interprets, and present s GCP com pliance data for management metric review meetings and for continuous improvement.

• Supports and prepares teams for regulatory inspections and / or corporate audits as directed. E nter and track Health A uthority inspection information and reports in database.

• Mentors and trains junior auditors. Provide technical guidance, leadership, and coaching of audit related activities. Performs auditor certification process and assessments for new auditors .

• Provide s guidance, review, and approval of associated deviations (NCI, & CAPAs) . If necessary, l ead and support the investigation of deviations and other quality issues detected from any source. Accountable for CAPA follow up and verification activity jointly with Clinical Development.

• Provides QA support to Supplier Evaluation Teams as needed and conducts GXP audits as assigned .

• Stays current on activities in Clinical by reviewing list of ongoing studies and attend ing Study Review and Project Kick-Off Meetings.

• Supports additional CQA initiatives and other cross- functional duties as assigned.

EDUCATION AND MINIMUM REQUIREMENTS

Bachelors Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

The ability to fluently read, write, understand and communicate in English

2 Years of Relevant Experience

Preferred Experience and Qualities

• 5 years experience in medical device and/o r pharmaceuticals audits

• 3-5 years in GCP auditing role

• Knowledge of ISO 14155, ICH 6, Medical Device EU and FDA regulatory requirements and Declaration of Helsinki.

• P roven GCP audit track record .

• Good Analytical Skills and Judgement

• Advocate for exceptional quality and compliance standards does not compromise on cu stomer expectations and regulatory requirements

TRAVEL REQUIREMENTS

As required up to 60%+ travel

OTHER DIME NSIONS AND SKILLS

• Ability to assess / judge critical issues and initiate escalation .

• I ndependently plan, schedule aud i ts and issue audit reports .

• Plan travel and expenses within budget and submits T&E reports on time.

• Contributes to annual budget planning.

• Prepares and manages Alcon Audit Plan as assigned .

Skills / Values/ Behaviors

• Communicates Effectively

• Collaboration

• Situational Adaptability

• Manages Conflict

• Resourcefulness

• Good Interpersonal skills

• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaboration

HOW YOU CAN THRIVE AT ALCON:

• Join Alcons mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!
  

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Total Rewards

Alcons Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcons Corporate Social Responsibility including our Total Rewards, click here

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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.