Sr Mgr QA Auditing-Remote
The Sr Manager QA Auditing is a key position in the Quality Assurance and Auditing group and will provide professional expertise, guidance, and leadership for the GCP, GLP, and/or GVP Audit Program and Audit Team. This individual will create strategic partnerships and direct risk-based quality auditing activities across Global Development (GCP/GVP/SUB) and/or Preclinical Development (GLP). Additionally, this individual will oversee GCP, GLP, and/or GVP audit team and ensure audits are executed appropriately. The Sr Manager QA Auditing applies expertise in Good Clinical, Good Laboratory, and/or Good Pharmacovigilance Practice (GxP) and international regulations and guidelines to the auditing process to independently address a variety of compliance issues associated with drug development and post-marketing authorization. The individual should have an expert 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:
+ Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.)
+ Assists with the management of resources & staff to accomplish the annual audit schedules.
+ Responsible for managing and developing direct reports.
+ Provide leadership, guidance, and supervision to direct reports and other staff as required.
+ Assist with the assessment and prioritize both internal and external audit needs.
+ Liase with Quality Assurance and cross functional teams to facilitate the adequate closure of audits.
+ Represent QAA on teams, compliance projects and initiatives both within and across functional areas of Global Development to ensure compliance with related regulations and internal procedures.
+ Identify training opportunities for current staff.
+ Assist in the selection, training and overseeing the onboarding of contract auditors.
+ Assist with leading or providing strong support to audits as needed.
+ Assist with the drafting and and issuance of periodic metrics reports to management, cross functional groups and leadership teams as requested.
+ Delegate as necessary tasks and duties to other functional staff.
+ May assist in the conduct and act as a subject matter expert in regulatory facility inspections.
This role might be for you if:
+ Bachelor's degree ( Master's degree preferred) with 11+ years of relevant industry experience
+ 9+ years' experience direct audit experience and/or 3+ direct supervisory or leadership experience
+ Excellent communication skills and ability to work with people in all levels of the organization and externally.
+ Demonstrated skills in taking initiative and working independently
+ Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
+ Demonstrated experience in driving Quality into the Clinical Trial Operations processes
+ Self-motivated with the ability to work effectively in a dynamic environment with ambuiguity
+ Strong leadership with demonstrated ability to interface with senior leaders
+ Good problem solving, written and verbal communication skills
+ Ability to effectively manage multiple priorities with a sense of urgency
+ Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
+ Attention to detail and accuracy of work
+ Minimum of 11 industry with 9 years auditing and 3 years management experience.
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.