Manager, Manufacturing Quality Assurance

Curia • Albuquerque, NM

2d • Onsite

About The Position

Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Requirements

• BS or BA in Science, Chemistry or Biology.
• Minimum of five (5) years quality assurance, regulatory compliance management or related work experience
• Minimum of two (2) years in a team leadership role of professional level individual contributors
• Minimum of five (5) years in an aseptic/sterile product facility
• Demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing
• 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, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
• Strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
• Adeptness in manufacturing and internet software, alongside 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, 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, with the ability to clearly express ideas in a logical, concise, and grammatically correct manner
• Strong organizational skills with the ability to manage multiple projects and priorities
• Skilled in interpreting and applying technical writing, procedures, and instructions
• Effective interpersonal skills with adaptability to achieve company goals collaboratively
• Available to support production operations on a 24/7 on-call basis
• Proficient in root cause analysis and troubleshooting
• Knowledge of aseptic processing techniques and ability to train and guide QA and production staff
• In-depth understanding of regulatory and quality standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA, MOH, EMEA, and FDA
• Experience with Quality Systems, including SOP development and control, computerized system validation (21 CFR Part 11), and sample distribution per PDMA
• Demonstrated leadership in audits and serving as a QA subject matter expert
• Proven ability to work independently and lead teams with strategic and innovative thinking
• Must pass background check
• Must pass drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Minimum of 10 years of progressively greater responsibilities in the pharmaceutical products/medical services industry, including QA, Regulatory, Operations, Project, Technical, and Laboratory experience, preferred
• Experience working with third-party contract manufacturing in the Pharmaceutical industry, strongly preferred

Responsibilities

• Provide daily Quality Assurance oversight and leadership to support commercial manufacturing operations, including in-process inspections, final product inspections, and on-the-floor batch record reviews.
• Serve as the primary Quality contact for internal departments regarding product, process, and material issues.
• Ensure timely resolution of quality issues to support uninterrupted manufacturing and compliant lot release.
• Maintain 24/7 availability to support urgent manufacturing or quality-related inquiries.
• Oversee and support Quality elements of validation activities, including report closures and adherence to protocol requirements.
• Review and approve quality documentation including investigations, change controls, and deviations.
• Hire, train, supervise, and develop the Manufacturing Quality Assurance (MQA) team, conducting regular performance evaluations to maintain a high-performing team.
• Provide cGMP training and mentoring to Quality and Production personnel to reinforce compliance and quality culture.
• Lead and support site-level and cross-functional strategic quality initiatives and global projects involving product changes, process improvements, or service enhancements.
• Drive continuous improvement efforts focused on quality, compliance, and operational efficiency in alignment with current regulatory expectations and industry best practices.
• Collaborate with other functional leaders to maintain alignment between quality and production goals.
• Act as the resident QA expert for manufacturing operations, providing technical guidance on compliance, product release, inspection readiness, and issue resolution.
• Ensure that all manufactured products meet regulatory, customer, and internal requirements for quality, safety, and efficacy.
• 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 with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Manager