Strategic QA Auditor

Location
Basking Ridge, NJ, United States
Posted
Sep 04, 2020
Ref
20643BR
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY:
The Manager QA Auditor is a key position in the Quality Assurance and Auditing group and will provide guidance and leadership for the GCP, GLP, GVP, or SUB Audit Programs and audits. The Manager will create strategic partnerships and implement risk-based quality auditing activities across Global Development or Preclinical Development (GLP). They will apply expertise in Good Clinical, Good Laboratory, and/or Good Pharmacovigilance Practice (GxP) and international regulations to the auditing process to independently address a variety of GxP compliance issues associated drug development and post-marketing authorization.

A TYPICAL DAY MIGHT INCLUDE THE FOLLOWING:

- Scheduling, preparing and conducting audits in support of GxP audits as directed. Audits include internal audits and external audits conducted globally.

- Assembling and leading the activities of the audit team.

- Reporting findings to management with recommendations for resolution and verifying appropriate CAPAs

- Owning the identification of internal quality/compliance issues and acting as a catalyst for process improvements

- Supporting clinical studies as study representative to develop and execute risk-based audit plans for assigned studies (GCP), as needed

- Interpreting policies, standards, and regulations, and evaluates potentially critical problems, and exercising judgment in ensuring that written procedures are followed

- Providing education and/or training to GxP functional areas as well as a recognized trainer of new Quality Assurance staff.

- Assisting with cross-GxP audits as needed.

THIS ROLE MAY BE FOR YOU IF:
You enjoy problem solving, and have strong communication skills

You have the ability to effectively manage multiple priorities with a sense of urgency

You can demonstrate your consistent track record of project management, stakeholder management, collaboration skills and negotiation of complex situations

You have excellent attention to detail and accuracy of work

You are self-motivated with the ability to work effectively in a dynamic environment with ambiguity

You have strong leadership with demonstrated ability to interface with senior leaders

You can take the initiative and work independently

To be considered for this role you must have a Bachelor's degree with 9+ years of relevant industry experience, 7+ years of direct GCP audit experience is preferred. We also require experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. You should have expert knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development. You are expected to have a deep level of knowledge and experience in conducting multiple audit types (e.g. process, laboratory, site, vendor, license partner, etc.).

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-EG1