Quality Assurance/Quality Control Manager

Looking for a new job opportunity in a growing, international, and dynamic Biotech company? About the Role We are looking for an experienced Quality Lead. This individual will work within our growing team to work with department managers to develop and implement policies to support a culture of quality. This individual will develop an understanding of quality and regulatory needs surrounding clinical testing services, as well as, diagnostic products.

Major Responsibilities:

QA/QS Lead is responsible for the oversight, optimization, and effectiveness of the company's Quality Management System (QMS), including product lifecycle quality, product disposition, supplier qualification, customer audit readiness, and quality system processes. This role requires a hands-on, pragmatic leader who ensures that quality system is fit-for-purpose, risk-based, and not over-engineered , supporting both a high-volume RUO product portfolio and a limited number of GMP-grade materials. This role is also responsible for oversight and approval of quality system elements including deviations, CAPA, change controls, and product release processes, while ensuring efficient and scalable operations that support business performance and do not create unnecessary operational burden.

Specific Duties:

• Design, implement, maintain, and continuously improve the company's Quality Management System (QMS) to ensure it is effective, scalable, and aligned with business needs without unnecessary complexity.
• Evaluate existing quality processes and systems to identify: ○ Redundant or low-value activities ○ Bottlenecks in product release or review ○ Opportunities for simplification and efficiency
• Challenge existing quality practices and systems where they do not add value, and implement practical improvement.
• Provide Quality support and direction to cross-functional teams, including Manufacturing, Packaging, Warehouse, and Product Development.
• Ensure appropriate risk-based application of quality requirements , differentiating between: ○ Research Use Only (RUO) products ○ GMP-grade products (limited scope)
• Provide oversight and approval, as appropriate, for: ○ Deviations and investigations ○ Out-of-Specification (OOS) results ○ Corrective and Preventive Actions (CAPA) ○ Change controls related to manufacturing processes, specifications, and test methods
• Ensure that investigation and CAPA processes are effective, timely, and appropriately scaled to risk , avoiding unnecessary complexity.
• Provide QA oversight of QC operations, ensuring: ○ Efficient and consistent product release processes ○ Appropriate review of batch records and Certificates of Analysis (CoAs) ○ Support for high-throughput release across a large SKU portfolio (5,000+ products)
• Partner with QC Manager to ensure alignment between QA expectations and QC execution without creating operational bottlenecks.
• Lead and support customer audits, supplier audits, and qualification activities , ensuring the organization maintains a consistent state of audit readiness.
• Prepare Manufacturing and Operations teams for audits and inspections, ensuring readiness without overburdening processes.
• Own and drive responses to audit findings, including: ○ Root cause analysis ○ CAPA development and implementation ○ Timely closure of actions
• Maintain oversight of supplier quality programs, including: ○ Supplier qualification and performance monitoring ○ Quality agreements with key suppliers ○ Investigation and resolution of supplier-related quality issues
• Provide guidance and training on quality systems, including: ○ Deviations and investigations ○ Change control ○ CAPA processes ○ Audit readiness
• Ensure quality systems support efficient lifecycle management and product disposition decisions.
• Establish and monitor key quality performance metrics, including: ○ Product release cycle time ○ Right-first-time rates ○ CAPA effectiveness and closure timelines
• Drive continuous improvement initiatives based on data and operational feedback.
• Supervise Quality staff, including: ○ Training and development ○ Performance management ○ Work prioritization and oversight
• Work cross-functionally to ensure quality systems are: ○ Understood ○ Practical to execute ○ Consistently applied
• Act as a Subject Matter Expert (SME) on quality systems and risk-based decision making.
• Other duties as assigned by supervisor.

REQUIREMENTS

Education

• BS or MS in a scientific discipline (Life Sciences, Chemistry, Engineering, or related field) Experience
• 8-15 years of experience in QA/QC within life sciences, biotech, diagnostics, or chemical environments
• Experience working in small to mid-sized organizations
• Demonstrated experience in: o Improving and simplifying quality systems o Supporting or leading customer and supplier audits o Working within high-volume or multi-product (high-SKU) environments preferred
• Experience overseeing or partnering with QC operations Technical Competencies
• Strong knowledge and application of: o Quality Management Systems (QMS) o Deviations, CAPA, and change control processes o Product release and batch/CoA review
• Familiarity with ISO-based quality systems (e.g., ISO 9001)
• Working knowledge of GMP principles (applied appropriately based on product type)
• Ability to apply risk-based decision making in quality systems Behavioral Competencies
• Strong problem-solving and decision-making skills
• Ability to simplify processes and reduce unnecessary complexity
• Willingness to operate at both strategic and tactical levels, including hands-on involvement in quality processes when needed
• Effective communication and cross-functional collaboration skills
• Ability to balance compliance requirements with operational efficiency
• Comfortable working in a hands-on, fast-paced environment
• Ability to influence without over-controlling and to challenge existing practices constructively

Job Type:

Full-time Pay:

$100,000.00 - $115,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance

Education:

Bachelor's (Preferred)

Experience:

QA/QC:

8 years (Preferred)

Work Location:

In person