Manager QA Auditor - Strategy

Tarrytown, NY, United States
Apr 24, 2021
Required Education
Bachelors Degree
Position Type
Full time
The Manager QA Auditor-Strategy is a key position in the Quality Assurance and Auditing group and will provide mentorship and leadership for the management of the GCP Audit Programs. We expect you will build strategic partnerships and direct risk-based audit activities with Global Development departments. The Manager QA Auditor-Strategy provides support and oversight of multiple assigned molecules, clinical studies and audit programs within the GCP Strategy. They are the liaison between the Global Development organization and audit teams. They are responsible for the full life cycle of the molecules to which they are assigned, executing audit risk assessments, developing audit plans, setting audit strategy, supporting auditors and providing metrics reports to study team. Additionally, you will be responsible for assigned audits; the number and type of audits assigned will be dependent on their workload and audit schedule.
In this role, a typical day might include the following:

Partner with key departments to develop risk-based audit planning for assigned molecules and studies as well as vendors and processes, as needed.

Maintain strategic audit plans based on risk indicators from study teams and the development organization.

Ensure audits are conducted in accordance with the approved audit plans and schedules.

Maintain relevant core study specific information to assist auditors with audit preparation and conduct.

Utilize audit outcomes to identify quality related trends and communicate compliance risks to the organization.

Contribute to the development and lead the implementation of continuous quality improvement initiatives.

While not a primary role, the strategy group may also schedule, prepare and conduct audits in support of GCP Audit group as needed.

Assembles and coordinates the activities of the audit team.

Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.

Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.

Appropriately escalate any compliance issues.

Manages and supports post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.

May assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.

Drafts and issues periodic reports to QAA and Global Development management as requested.

Provides education and/or training to GCP functional areas as well serve as a recognized trainer of new QA staff assisting with their orientation.

Assist QAA management with other ad-hoc QAA activities
This role might be for you if:
  • Bachelor's degree (Master's degree preferred) with 9+ years of relevant industry experience (may substitute relevant experience in lieu of education requirement)
  • 7+ years of direct GCP audit experience preferred
  • Excellent communication and organizational 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.
  • Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
  • Strong leadership with proven track record of collaborating with senior leaders
  • Good problem solving, written and verbal communication skills
  • Ability to lead multiple priorities.
  • Strong track record of project management, stakeholder management, collaboration skills and resolve sophisticated situations
  • Attention to detail and accuracy of work

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.