Director, Drug Product Quality

East Greenbush, New York, United States of America
Jul 18, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Director Quality Assurance (Drug Product) position. This position provides the quality support and oversight for Aseptic drug product filling, and packaging and labeling. This consists of new fill finish facility start up and any other Drug Product project supported. The position will be responsible for the QA DP team including: AQL visual inspection, on the floor quality, quality engineer, label control, and batch record/MES review. 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.

In this role, a typical day might include the following:
• Build and execute a business strategy that translates vision and goals into departmental objectives
• Builds and maintains a robust 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 encourage others
• Drives departments for efficient performance and constantly raises the bar, accountable for the performance and results of a department
• Provide career development and training advice. Provide regular feedback to team members on company and departmental operations
• Advises the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities
• Lead cross functional teams and manages the results for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints. Connect with senior management to report on project and program achievements and to present project needs
• Accountable for ensuring policies, procedures, and standards are consistently followed and adhered to on a consistent basis; and changes policies, procedures and standards as appropriate to ensure the highest quality standards are maintained
• Provides first response for Quality and Compliance issues on the manufacturing floor
• Provides 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 communicating 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
• Responsible for implementing and improving operational and strategic policies and directives
• Develops or supports program development for visual inspection, component qualification, on the floor quality, aseptic qualification, aseptic process simulation, filling batch records, assembly and pack& label, segregation/hold process

This role might be for you if you:
• Have held a Quality Operations, Quality Management or manufacturing role, in a late stage or early stage start-up Drug Product company
• Have 10+ years' experience in a cGMP controlled/pharmaceutical industry with regulatory requirements
• Have had 4+ years in a leadership role
• Have experience with aseptic processing and visual inspection, pack and label, component qualification, and sampling plans
• Are able to influence others to achieve results and to challenge the status quo

To be considered for this role you must hold a Bachelor's degree in Life Sciences and the following minimum amounts of pharmaceutical/biotechnology industry experience for each level:
• Associate Director - 10+ years
• Director - 12+ years,
• Sr Director - 15+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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.