Manager, Manufacturing Quality Assurance

Curia • Albuquerque, NM

1d • Onsite

About The Position

The Manager, Manufacturing Quality Assurance (MQA) is responsible for directing and overseeing all MQA activities to ensure consistent quality support of daily manufacturing operations and product lot release. This role serves as the primary Quality liaison for internal departments, providing guidance on product, process, and material issues while ensuring adherence to regulatory, corporate, and customer quality standards. Key responsibilities include in-process and final product inspections, on-the-floor batch record review, 24/7 QA oversight, and support for validation, change control, and deviation investigations. The MQA Manager leads the hiring, training, and development of MQA staff and drives continuous improvement initiatives aligned with current regulations and best industry practices. Additionally, the role supports strategic and global quality projects, fosters cross-functional collaboration, and ensures that all manufacturing operations consistently produce safe, effective, and high-quality products.

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.
• 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

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