Associate Director, Quality Assurance

　　Rensselaer, NY

　　Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

　　Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

　　We proudly offer:

　　Generous benefit options (eligible first day of employment)

　　Paid training, vacation and holidays (vacation accrual begins on first day of employment)

　　Career advancement opportunities

　　Education reimbursement

　　401k program

　　Learning platform

　　And more!

　　Summary:

　　The Associate Director (AD) is an essential part of the Quality Management team. The Associate Director is responsible for the QA oversight, and will report to the Site Quality Head. This position also requires frequent interactions with customers to provide the quality updates on the ongoing client projects and articulate Curia’s position on various quality topics.

　　Responsibilities:

　　Lead and mentor quality assurance team at Curia New York, Inc

　　Provide developmental feedback and coaching and create a collaborative environment for direct reports

　　Responsible for improving the overall department productivity and efficiency working site’s cross functional teams

　　Develop and establish processes and procedures to streamline quality operations of Curia New York, Inc, in line with FDA, current industry and/or Corporate Curia standards

　　Influence across the organization to establish a culture of excellence and right-first-time execution

　　Responsible for improving and maintaining the site quality systems

　　Collaborate with other stake holders to ensure all development and commercial programs meet the site quality objectives

　　Lead the site quality boards, reviews and/or approves complex (majors and critical) investigations to ensure robust root cause analysis and effective timely closure

　　Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the Quality Assurance function

　　In partnership with cross-functional teams, contribute to continuous improvement of the investigations, Change Control, CAPA, and product complaints programs.

　　Act as company’s representative during regulatory agencies and customer inspections and support site quality head

　　Review and manage customer quality agreements in accordance with company standards

　　Effectively communicate with internal and external customers making sure that the Curia’s values and quality objectives are consistently achieved.

　　Exhibit safety awareness and safe work practices

　　Perform other duties as may be reasonably assigned in the course of business

　　Ensures continued staffing for highly dynamic site operations

　　Knowledge & Skills:

　　Experience in building and growing an organization into a high-performance team.

　　Strong background and demonstrated effectiveness in quality assurance operations.

　　Demonstrated leadership, interpersonal, communication, and motivation skills.

　　Knowledge of US and EU cGMP regulations and guidance.

　　Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking

　　Knowledge and proven experience in interacting with corporate auditors and regulatory authority (FDA, EMA, PMDA etc) inspectors.

　　Experience with investigations, root cause analysis and implementation of effective corrective and preventative actions, including CAPA effectiveness planning.

　　Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision and confident in making decisions for medium level issues

　　Must possess an independent mindset, tenacity and agility suited for commercial dynamic environment.

　　Routinely recognizes Quality issues and proactively solves problems.

　　Required Qualifications :

　　Bachelor of Science in Physical Sciences, Engineering, related discipline is required.

　　Minimum of 10 years’ experience in related cGMP environment: API or Drug product operations.

　　6 years' experience within QA. Preferably experience in CMO/CDMO organizations

　　Pay Range:

　　$118,000 - $147,200

　　Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

　　All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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