Director, Quality Operations

Director, Quality Operations
Albuquerque, NM

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:
Director of Quality Operations is responsible for CGMP Quality Operations of the facility inclusive of Incoming QA (IQA), Manufacturing QA (MQA), Aseptic Core Monitoring (ACM), Sterility Assurance, and Client QA.  Quality Operations reviews and approves regulated documents and records including for example SOPs, Master Batch Records, Master Packaging Records, Protocols, Reports, Deviations, CAPAs, and Change Controls.  Quality Operations is responsible for the review of executed records to ensure timely disposition of batches.  This role works with internal and external customers to resolve quality issues and proactively identify areas of opportunity utilizing metrics to drive priorities.  Quality Operations works with Quality Compliance to evaluate deviations related to production batches, the laboratories, and the facility.  Quality Operations is the primary Quality contact for all internal and external customer interactions with respect to Quality Operations and supports other quality organizations (QSYS, QC, VAL) with external customer interactions.

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.
• Establish and maintain department escalation plan.
• Establish and maintain department tier structure.
• Establish and maintain department policies.
• Establish and maintain department budget.
• Other duties as assigned

Supervisory Responsibilities:                                                  
This job has supervisory responsibilities

Education and/or Experience:                               

Bachelor's degree in a scientific or related field from four-year college or university and minimum of ten (10) years of progressively greater responsibilities in QA in the pharmaceutical/medical devices, including project, technical, and personnel management.  Minimum of seven (7) years in an aseptic/sterile product facility required. Experience strongly preferred working within third-party contract manufacturing in the Pharmaceutical industry including client-facing roles.

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

Language Skills:  

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly and speak effectively.          

Mathematical Skills:                                                    

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.  

Other Skills and Abilities:                                           

• 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.). 

Physical Demands:
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Work Environment:
While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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.