Curia · 2 weeks ago
Director, Quality Operations
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Director of Quality Operations oversees CGMP Quality Operations and is responsible for reviewing and approving regulated documents, ensuring timely disposition of batches, and collaborating with internal and external customers to address quality issues.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
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
Ability to read and interpret various documents including safety instructions, standard operating procedures, technical procedures, and governmental regulations
Strong written and verbal communication skills
Effective presentation skills
Strong technical foundation and proven capability in effectively utilizing diverse software tools
Adeptness in manufacturing and internet software
Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
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
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
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Preferred
Knowledge in design of building management systems and cleanroom aseptic facilities
Knowledgeable with regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.)
Benefits
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!
Company
Curia
Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.
H1B Sponsorship
Curia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2025-03-07Debt Financing
2017-08-31Private Equity
Recent News
2025-10-31
thecanadianpressnews.ca
2025-10-29
Curia Global, Inc.
2025-10-27
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