The Regeneron Associate 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. You should have in-depth knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development and post-authorization safety monitoring including HIPAA Privacy Rule, and other international and national rules as applicable.
In this role, a typical day might include the following:
- Schedules, prepares and conducts audits in support of GxP audits as directed and in accordance with company SOP's Audits include internal audits and external audits conducted globally.
- Reports findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.
- We expect you to represent QAA on teams, compliance projects and initiatives both within and across functional areas of Global Development, PVRM, Commercial, Preclinical Development, or other departments, as applicable.
- May support clinical studies as study representative to develop and implement risk-based audit plans for assigned studies (GCP).
- Appropriately addresses any compliance issues.
- May assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
- Drafts and issues periodic reports to site management as requested
This role may be for you if:
- You have excellent interpersonal skills and ability to work with people in all levels of the organization and externally.
- We seek candidates with proven skills in taking initiative and working independently
- Self-motivated with the ability to work effectively in a dynamic environment
- Strong leadership with demonstrated ability to work with senior leaders
- Good problem solving, written and verbal communication skills
- Ability to effectively manage multiple priorities with a sense of urgency
- Attention to detail and accuracy of work
To be considered you should have Bachelor’s degree with 7+ years of relevant industry experience. 5+ years of direct GCP, GLP, or GVP audit experience preferred. We look for experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs, as applicable.
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 parental 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.