Director Quality Engineer Fda Jobs in Indiana (NOW HIRING)

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, Quality Assurance to provide the quality support and oversight for drug substance manufacturing operations at the Regeneron Drug Substance (DS) facility. The position is responsible for the QA DS team overseeing any or all of the following production processes: cell culture, centrifugation, chromatography, ultrafiltration/diafiltration (UFDF), and aseptic dispensing of bulk drug substance. The director will provide the leadership, direction, and the overall Quality oversight of the manufacturing area ensuring they meet current FDA and International Regulatory Body requirements.

When & where:

• Location: Rensselaer, NY

• Work model: Monday-Friday, 8am-4:30pm

Discover your role:

• Build and execute a business strategy that translates vision and corporate goals into departmental objectives

• Builds and maintains a high performing team of managers, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments. Sets the course for the future- defines priorities, goals and objectives for quality team

• Provide direction, set performance standards, evaluate, develop performance and inspire direct reports

• Ensure quality floor staff are appropriately trained to support plant operations, ensuring risks are identified and resolved. Responsibilities include in-process testing oversight, line clearance checks (as necessary), batch record review, return to service requirements have been met and quality-on-the-shop-floor responsibilities of first response to product quality issues in production

• Provide career development and training advice. Provide regular feedback to direct reports on company and departmental operations

• Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities

• Lead cross functional teams and manages the deliverables for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints. Interfaces with senior management to report on project and program milestones and to present project needs

• Provides escalated response for Quality and Compliance issues on the manufacturing floor and assures that decisions are made at the proper level and with the appropriate insights.

• May provide review and final QA approval of deviations, and other quality events; protocols/reports; change documentation, SOPs; master batch record approval

• Ensures product, facility, and equipment holds are placed when batch, equipment or system integrity is questioned

• Responsible for representing the Company and directly interfacing with auditors during regulatory body inspections

• Ensures periodic informal audits are completed in production

• Leads teams for tracking of quality activities, metrics, CAPA tracking, etc. Reports metrics and assesses data trends to work with operating departments to facilitate process improvements

• Develops or supports procedure and process development for continual improvement of cell culture operations, centrifugation/harvest, chromatography, UFDF, viral clearance, aseptic dispensing, filling batch records, and segregation/hold process

• Provide leadership and direction to the manufacturing and support area departments to ensure a constant state of inspection readiness

• Requires the ability to influence others to achieve results and to challenge the status quo

This role requires:

• Bachelor's degree in Life Sciences or related field, or equivalent combination of education and experience, and a minimum of 12 years experience in a Quality Operations, Quality Management or manufacturing role, in a late stage or early stage start-up Drug Substance/biologics company

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$172,200.00 - $286,900.00