We are currently looking to fill an Associate Manager, QA Investigations position. This position is responsible for providing oversight of the quality review, quality approval and management of deviation events, investigations and CAPA.
In this role, a typical day might include the following:
Manages a team with direct oversight of review and approval for deviations, laboratory investigations and corrective actions.
May review, verify and approve system records.
Collaborates across QA to provide succinct support to investigation teams to drive quality outcomes.
Approves and reviews SOP revisions.
Provides direction for cross-functional study team meetings and interacts with subject matter authorities.
Provides input for error prevention and corrective actions based on investigational findings.
Involved in post-production management of events as required to facilitate closures to meet the required timelines.
Serves as a subject matter authority to present topics to management and during inspections.
Monitors quality system metrics including deviations, corrective actions, change management and controlled document workflows.
Drafts and implements long-term planning for the process, staff and budget.
Performs personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.).
Makes decisions and develops and implements policies.
Ensures that policies and procedures are effectively coordinated and follow regulatory requirements and current good manufacturing practices (cGMPs).
This role may be for you if you:
Have previous quality experience in the pharmaceutical industry
You continuously seek to improve processes for improved performance
Enjoy leading a team of Quality minded professionals
To be considered for this role you must hold a BA / BS degree in Life Sciences or related field and 6+ years of relevant cGMP manufacturing experience. Also, must have 3 years of supervisory experience. May substitute proven experience for education requirement.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
