Director, Quality Operations

Director, Quality Operations

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 Director of Quality Operations oversees CGMP Quality Operations, including Incoming QA (IQA), Manufacturing QA (MQA), Aseptic Core Monitoring (ACM), Sterility Assurance, and Client QA. This individual is responsible for reviewing and approving regulated documents and records, such as SOPs, Master Batch Records, Master Packaging Records, Protocols, Reports, Deviations, CAPAs, and Change Controls. The Director ensures timely disposition of batches by reviewing executed records and collaborates with internal and external customers to address quality issues and proactively identify improvement opportunities using metrics to prioritize initiatives. They work closely with Quality Compliance to assess deviations related to production batches, laboratories, and facilities. As the primary Quality contact for internal and external customer interactions regarding Quality Operations, the Director also supports other quality functions, including QSYS, QC, and Validation, during external engagements. This role is central to maintaining compliance, fostering collaboration, and driving continuous improvement across the organization.

Essential Duties and Responsibilities : + Direct the Incoming QA (IQA), Manufacturing QA (MQA), Aseptic Core Monitoring (ACM), Sterility Assurance, and Client QA teams to ensure that planned objectives are achieved + Develop and implement an effective department organization to achieve goals and objectives + Ensure adequate levels of personnel are maintained to meet requirements based on resource model + Ensure appropriate support of operations including in-process inspection, final product inspection, in-process (real-time) batch record review, routine operations quality support including line clearance, room release, and record review activities + Ensure effective in-process (real-time) and final batch record review processes support batch disposition decisions within established timelines (TATs) and incorporate continuous improvement feedback to reduce the overall number of errors, deviations, and comments + Ensure customer relationships are managed and maintained effectively to achieve desired outcomes + Work with internal and external customers to resolve quality issues and proactively identify areas of opportunity utilizing metrics to drive risk-based prioritization of improvement efforts + Establish and report daily / weekly / monthly / quarterly / annually (as applicable) department metrics + Ensure GMP areas and responsibilities are maintained in permanent inspection-ready state + Ensure timely identification, investigation, correction, and resolution of deviations + Develop and support departmental strategic goals to assure the highest quality standards + Work with other departments to achieve site priorities, goals and objectives + Mentor, coach and train department personnel to increase the level of technical skills + Meet with direct reports regularly (1 : 1) as part of regular performance management + Maintain department curriculum and training oversight for staff + Establish and maintain department resource model, escalation plan, tier structure, policies, and budget. + Read / interpret SOPs to ensure compliance + Maintain up to date trainings + Other duties as assigned

Education and Experience : + Bachelor's degree in a scientific or related field from an accredited four-year college or university + Minimum of ten (10) years in Quality Operations or relevant related work experience + Minimum of ten (10) years' experience in a pharmaceutical / medical devices, including project and technical management + Minimum of five (5) years' experience in a professional management role

Supervisory Responsibilities : This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language Skills : The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.

Computer Skills : The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities : + Leads with integrity and respect + Provides guidance, coaching, and mentorship to team members + Demonstrates business acumen + Fosters a collaborative and positive work environment + Champions change + Coaches and Develops + Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members. + Demonstrates strong attention to detail + Excellent Communication skills, both verbal and written. + Ability to organize time in order to successfully manage multiple projects and priorities. + Ability to read, understand, interpret and implement technical writing and instructions. + Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals. + Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style. + Prefer knowledge in design of building management systems and cleanroom aseptic facilities. + Knowledgeable with regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.).

Other Qualifications :

Physical Demands : The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The essential physical demands will vary for each Curia position. All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment : The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and / or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials. Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection. All environments may be subject to working with or being exposed to cleaning agents.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended. 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. Curia is an E-Verify employer.