Manager, Manufacturing Quality Assurance

Manager, Manufacturing Quality Assurance in Albuquerque, NM

Our client provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

Our client proudly offers:

• 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:

The Manufacturing Quality Assurance (MQA) Manager leads all activities related to daily product manufacturing and lot release. As the primary Quality contact for internal teams, the MQA Manager spearheads initiatives to resolve product, process, and material issues. Key responsibilities include directing manufacturing quality operations, overseeing in-process and final product inspections, managing batch record reviews, supporting validation efforts, and addressing customer batch release queries. The role ensures that all products consistently meet regulatory, corporate, and customer standards for quality, safety, and efficacy.

Essential Duties and Responsibilities:

• Direct and manage the Manufacturing Quality Assurance activities, to include on the floor batch record review and 24/7 Quality Assurance oversight of manufacturing processes.
• On call to answer quality questions from Quality Assurance and Production employees as needed.
• Provide manufacturing and Quality Assurance technical expertise to internal departments.
• Provide training on cGMPs to the QA group and Production as needed.
• Provide support on validation report closure, change control, investigation approval and other QA systems related issues.
• Direct and manage strategic/global projects by working with all plant management groups on new products, changes to products, and services to achieve a consistent approach to Quality as needed.
• Support quality and compliance process improvements and goals for the sites using current regulations and best-demonstrated practices as needed.
• Direct effective and efficient continuous quality and cost improvement efforts as needed.
• Hire, train and develop MQA staff and conduct Performance Reviews to assure highly effective, team-oriented contributors.
• Develops and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
• Serves as resident QA expert in support of all manufacturing quality assurance functions (product release, product inspection, batch record reviews, compliance) and resolution of issues on the production floor
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings

• Other duties as assigned

Education and/or Experience:

• Bachelor’s degree in in Science, Chemistry, Biology or related field of study
• Minimum of five (5) years in Quality Assurance or Regulatory Compliance Management
• Minimum of two (2) years in a leadership role
• 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.
• Experience working with third-party contract manufacturing in the Pharmaceutical industry, strongly preferred
• 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

Supervisory Responsibilities:

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Other Skills and Abilities:

• 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
• Ability to organize time in order to successfully manage multiple projects and priorities
• Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals
• Willing to be on call to answer questions from production 24hours/7 days a week.
• Root cause analysis trouble-shooting experience.
• Knowledge of aseptic processing technique.
• Ability to train and advise QA professionals and production personnel. Knowledge of quality, regulatory and legal standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA, MOH, EMEA, and FDA.
• Knowledge of Quality Systems as they related to SOP creation and control, Validation of Computerized Systems per Code of Federal Regulations, Chapter 21, Part 11 and Sample Distribution per PDMA Prescription Drug Marketing Act.
• Provides leadership in supporting audits and services as the resident QA expert at site and among departmental staff.
• Must have demonstrated ability to work independently and as a team leader.
• Must show innovative development techniques and strategic thinking abilities.

Other Qualifications:

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

Must be able to obtain and maintain gowning certification

Must be able to obtain and maintain media qualification

Must be able to wear a respirator

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

Our client 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. Our client is an E-Verify employer.