Director, Quality Operations
Curia, Albuquerque, NM, United States
Director, Quality Operations
Location: Albuquerque, NM
Curia is a global contract research and manufacturing organization committed to excellence in pharmaceutical and biotechnology services.
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
401(k) 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. The Director reviews and approves regulated documents and records, ensuring timely batch disposition and collaborating with internal and external customers to address quality issues and identify improvement opportunities.
Essential Duties And Responsibilities
Direct the IQA, MQA, 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 based on resource model.
Support operations including in‑process inspection, final product inspection, batch record review, line clearance, room release, and record review activities.
Ensure effective real‑time and final batch record review processes support batch disposition decisions within established timelines.
Maintain customer relationships and manage quality issues to identify improvement opportunities.
Report daily/weekly/monthly/quarterly/annual department metrics.
Maintain GMP areas in perpetual inspection‑ready state.
Identify, investigate, correct, and resolve deviations.
Support departmental strategic goals and ensure highest quality standards.
Collaborate with other departments to achieve site priorities.
Mentor, coach, and train personnel to increase technical skills.
Conduct regular 1:1 meetings for performance management.
Maintain training curriculum and oversight.
Establish and maintain resource models, escalation plans, tier structures, policies, and budgets.
Interpret SOPs and maintain up‑to‑date training.
Perform 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 related experience.
Minimum of ten (10) years in pharmaceutical/medical devices, including project and technical management.
Minimum of five (5) years in a professional management role.
Supervisory Responsibilities This role leads and supports a team, overseeing day‑to‑day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures.
Language Skills Ability to read and interpret safety instructions, SOPs, technical procedures, and regulatory documents, along with strong written and verbal communication and presentation skills.
Computer Skills Proficient in manufacturing and internet software, and Microsoft Office tools (PowerPoint, Excel, Word, Outlook).
Other Skills And Abilities
Leads with integrity and respect.
Provides guidance, coaching, and mentorship.
Demonstrates business acumen.
Fosters a collaborative environment.
Champions change.
Develops and promotes a safe working environment.
Strong attention to detail.
Excellent communication skills.
Time management for multiple projects.
Interpret and implement technical writing.
Effective interpersonal skills, with adaptability.
Clear, concise verbal expression.
Knowledge of building management and cleanroom aseptic facilities preferred.
Knowledge of regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.).
Other Qualifications
Must pass a background check.
Must pass a drug screen.
May be required to pass Occupational Health Screening.
Physical Demands Typical physical demands include lifting, pushing, pulling up to 10–25 pounds and occasional lifting up to 50 pounds; regular sitting, standing, and reaching; visual acuity for close and distant tasks. Reasonable accommodations may be provided.
Work Environment Work environments vary: office, manufacturing, or warehouse. Manufacturing requires sterile conditions with proper PPE; warehouse may involve controlled temperatures; office may involve normal work noise. Some roles involve elevated heights, moving mechanical parts, and exposure to cleaning agents.
Equal Opportunity Employer 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.
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Curia is a global contract research and manufacturing organization committed to excellence in pharmaceutical and biotechnology services.
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
401(k) 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. The Director reviews and approves regulated documents and records, ensuring timely batch disposition and collaborating with internal and external customers to address quality issues and identify improvement opportunities.
Essential Duties And Responsibilities
Direct the IQA, MQA, 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 based on resource model.
Support operations including in‑process inspection, final product inspection, batch record review, line clearance, room release, and record review activities.
Ensure effective real‑time and final batch record review processes support batch disposition decisions within established timelines.
Maintain customer relationships and manage quality issues to identify improvement opportunities.
Report daily/weekly/monthly/quarterly/annual department metrics.
Maintain GMP areas in perpetual inspection‑ready state.
Identify, investigate, correct, and resolve deviations.
Support departmental strategic goals and ensure highest quality standards.
Collaborate with other departments to achieve site priorities.
Mentor, coach, and train personnel to increase technical skills.
Conduct regular 1:1 meetings for performance management.
Maintain training curriculum and oversight.
Establish and maintain resource models, escalation plans, tier structures, policies, and budgets.
Interpret SOPs and maintain up‑to‑date training.
Perform 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 related experience.
Minimum of ten (10) years in pharmaceutical/medical devices, including project and technical management.
Minimum of five (5) years in a professional management role.
Supervisory Responsibilities This role leads and supports a team, overseeing day‑to‑day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures.
Language Skills Ability to read and interpret safety instructions, SOPs, technical procedures, and regulatory documents, along with strong written and verbal communication and presentation skills.
Computer Skills Proficient in manufacturing and internet software, and Microsoft Office tools (PowerPoint, Excel, Word, Outlook).
Other Skills And Abilities
Leads with integrity and respect.
Provides guidance, coaching, and mentorship.
Demonstrates business acumen.
Fosters a collaborative environment.
Champions change.
Develops and promotes a safe working environment.
Strong attention to detail.
Excellent communication skills.
Time management for multiple projects.
Interpret and implement technical writing.
Effective interpersonal skills, with adaptability.
Clear, concise verbal expression.
Knowledge of building management and cleanroom aseptic facilities preferred.
Knowledge of regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.).
Other Qualifications
Must pass a background check.
Must pass a drug screen.
May be required to pass Occupational Health Screening.
Physical Demands Typical physical demands include lifting, pushing, pulling up to 10–25 pounds and occasional lifting up to 50 pounds; regular sitting, standing, and reaching; visual acuity for close and distant tasks. Reasonable accommodations may be provided.
Work Environment Work environments vary: office, manufacturing, or warehouse. Manufacturing requires sterile conditions with proper PPE; warehouse may involve controlled temperatures; office may involve normal work noise. Some roles involve elevated heights, moving mechanical parts, and exposure to cleaning agents.
Equal Opportunity Employer 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.
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