Director, Quality Operations

Curia • Albuquerque, NM

2d

About The Position

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.

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.

Requirements

• 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
• 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.
• 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.
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Prefer knowledge in design of building management systems and cleanroom aseptic facilities.
• Knowledgeable with regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.).

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

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!

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees