QA Manager

Job Description

Job Description

Job Title: QA Manager Job Description

The QA Manager leads the Quality Assurance department, overseeing staff, operations, and documentation to ensure full compliance with standard operating procedures, government regulations, and customer requirements. This role ensures company quality programs align with regulatory guidelines and industry standards, supports budgeting activities, and serves as a liaison with internal teams and external stakeholders. The QA Manager also plays an active role in recruiting and selecting QA team members while driving continuous improvement across all facilities and production shifts.

• Manage the Quality Assurance department, providing guidance and support to supervisors and team members while overseeing overall team performance.
• Ensure QA staff work toward company and departmental goals and maintain a strong focus on compliance, quality, and continuous improvement.
• Participate in performance management activities and other Human Resources-related processes for QA team members.
• Manage departmental operations across all company facilities and production shifts, ensuring consistent QA practices and standards.
• Participate in the recruitment and selection process for the Quality Assurance department to build and maintain a high-performing team.
• Review and approve production and quality documentation, including batch records, deviation reports, standard operating procedures (SOPs), investigative reports, and related documents, ensuring completeness, accuracy, and compliance with procedures, regulatory guidelines, and customer expectations.
• Prepare and revise SOPs, sample plans, and other production documents as required to support compliant and efficient operations.
• Investigate deviations and issues, write detailed reports, and provide status updates in accordance with procedures for deviation, investigation, and CAPA (Corrective and Preventive Action) reports.
• Serve as a departmental representative in internal and external meetings, including management meetings, FDA audits, customer inspections, and other regulatory or client-facing engagements.
• Provide CAPA updates and input on departmental metrics to support transparency and continuous improvement efforts.
• Act as a liaison on quality issues with customers and, as needed, assist with customer and supplier audits.
• Collaborate cross-functionally with other internal departments to address quality concerns, support operational goals, and maintain strong communication channels.
• Assist in maintaining the department budget and contribute to resource planning and allocation.
• Ensure that departmental operations align with cGMP, GDP, and relevant regulatory guidelines in a fast-paced, highly regulated environment.

• 13+ years of experience in a pharmaceutical, biotech, or regulated manufacturing environment.
• Working knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory guidelines.
• Strong analytical and problem-solving skills, with the ability to assess complex quality issues and develop effective solutions.
• Excellent communication skills, including the ability to clearly convey quality requirements and findings to diverse audiences.
• Strong documentation skills with a focus on accuracy, completeness, and compliance.
• Demonstrated ability to work effectively in a fast-paced, highly regulated environment.
• Attention to detail and accuracy in all aspects of quality assurance and documentation.
• Technical troubleshooting capabilities to address quality and process-related issues.
• Collaboration and cross-functional communication skills to work effectively with multiple departments.
• Time management and prioritization skills to handle multiple tasks and deadlines.
• Continuous improvement mindset, with a strong focus on enhancing quality systems and processes.
• Strong compliance and quality focus, ensuring adherence to internal procedures and external regulations.
• Experience with quality assurance, environmental monitoring, audits, quality control, quality checks, and inspections.

• Experience in sterile or aseptic operations and biologics is preferred.
• Knowledge of Six Sigma or other continuous improvement methodologies is a plus.
• Familiarity with batch records, inventory management systems, and Laboratory Information Management Systems (LIMS) is beneficial.

This role is primarily on-site in manufacturing areas, including cleanrooms and controlled environments. Work in classified areas may require appropriate gowning and adherence to strict environmental and contamination control procedures. The typical first-shift production schedule consists of four 10-hour days, with standard hours from 6:00 AM to 4:30 PM. The position requires availability for various days of the week and the flexibility to work a 5-day schedule as needed. The work environment is highly regulated, fast-paced, and focused on maintaining the highest standards of product quality and compliance.

This is a Permanent position based out of Syracuse, NY.

The pay range for this position is $95000.00 - $95000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits:401(k)401(k) matchingDental insuranceEmployee assistance programFlexible spending accountHealth insuranceLife insurancePaid time offParental leaveReferral programTuition reimbursementVision insurance

This is a Permanent position based out of Syracuse, NY.

This position is anticipated to close on Oct 31, 2026.

This is a fully onsite position in Syracuse,NY.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.