Catalyst Pharmaceuticals Jobs in Raleigh, NC (NOW HIRING)

Summary of the position:

The QA Operations Sr. Manager will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. 

The QA Operations Sr. Manager provides quality leadership and oversight across site operations, including materials, manufacturing, warehouse activities, quality interfaces, and product release. This role partners closely with cross?functional leaders to ensure robust processes, effective risk management, and consistent delivery of compliant, high?quality products. As a member of the Site Quality Leadership Team, the role drives a strong quality culture, supports continuous improvement, and translates regulatory expectations into practical, sustainable operational practices.

Essential Functions & Responsibilities:
Quality Oversight of Site Operations

• Provide independent QA oversight and partnership across all operational activities, including incoming materials, warehouse, manufacturing, QC, and product disposition. 

• Ensure operational processes are designed and executed in compliance with GMP, ALCOA+ data integrity principles, and internal quality standards. 

• Partner with operational leaders to ensure processes are robust, capable of right-first-time execution, and support operational decision-making. 

• Ensure timely escalation of significant quality risks to site leadership and the Head of Quality. 

• Apply quality risk management principles (ICH Q9) in all operational decision-making.

Quality Culture & Operational Excellence

• Act as a catalyst for a strong quality culture, providing guidance and coaching to operational teams. 

• Ensure QA presence in operations through Manufacturing QA and other QA Operations teams. 

• Translate regulatory expectations into practical, meaningful practices. 

• Promote proactive identification of risks, operational issues, and improvement opportunities. 

• Support teams in analyzing situations, addressing root causes, and implementing sustainable improvements. 

• Drive continuous improvement initiatives to enhance process robustness and operational performance. 

Oversight of Quality Events and Investigations

• Provide oversight for quality events impacting operations, including exceptions, non?conformances, and OOS results.

• Drive timely, scientifically sound investigations focused on root cause and effective, sustainable corrective and preventive actions.

• Responsible appropriate escalation, communication, and closure of significant quality events.

Batch Disposition & Product Release

• Oversee batch record review and product disposition processes. 

• Ensure robust review processes support compliant and timely product release. 

• Assess and address quality issues impacting batch disposition. 

Sterility Assurance

• Provide leadership for sterility assurance via the Sterility Assurance function. 

• Ensure implementation, maintenance, and continuous improvement of the site Contamination Control Strategy (CCS). 

• Oversee contamination control practices, aseptic manufacturing, environmental monitoring, and utilities microbiological risks. 

• Ensure compliance with regulatory expectations and industry best practices for sterile product manufacturing. 

Continuous Improvement & QA Operational Projects

• Lead QA-driven projects and cross-functional improvement initiatives. 

• Promote structured problem solving, risk management, and sustainable implementation of improvements. 

• Ensure QA support for operational transformations and site-level projects

• Performs other duties as assigned by management

Department Specific/Non-Essential Functions:

• Participate in site initiatives, inspections, audits, and special projects as assigned

• Support cross?functional quality improvement or cultural initiatives

• Provide mentorship, training, or ad hoc guidance to quality or operations staff

• Contribute to site readiness activities and leadership forums as needed

• Performs other duties as assigned by management
   

Education, Experience, and/or Skill:

Required Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Microbiology, Biotechnology, Chemistry, or related scientific discipline.

• 10+ years of progressive experience in Quality Assurance within a regulated pharmaceutical or biotech environment

• Extensive experience in pharmaceutical or biotech manufacturing under GMP regulations. 

• Strong experience in QA oversight of operations and sterile manufacturing preferred.  

• Proven leadership in managing QA teams in a regulated environment. 

Preferred Qualifications

• Experience in cross-functional operational settings and continuous improvement initiatives.  

• Experience partnering with Operations, Quality Control, Engineering, and Supply Chain

• Ability to influence across organizational levels and drive a strong quality culture

• Experience in continuous improvement initiatives (e.g., Lean, Six Sigma, or similar)

Physical Requirements:

• Capacity to work in both office and manufacturing environments

• Capability to sit, stand, and move throughout the facility for extended periods

• Occasional lifting and/or movement of materials up to approximately 20 pounds

• Proficiency with standard office equipment, including computer, keyboard, and phone

• Access to manufacturing, laboratories, warehouse, and controlled environments as required

• Ability to wear appropriate personal protective equipment (PPE) when required

Cognitive Requirements:

• Capacity to analyze complex information, assess risk, and exercise sound judgment in a regulated environment

• Demonstrated critical thinking and decision?making skills to balance quality, compliance, and operational priorities

• Proficiency in interpreting and applying regulatory requirements, policies, and procedures to operational scenarios

• Strong planning and prioritization skills to manage multiple initiatives simultaneously in a fast?paced setting

• Capability to identify root causes, evaluate trends, and develop effective, sustainable solutions

• Effective communication and influencing skills across all organizational levels

• Attention to detail combined with strategic perspective to understand broader business and quality impacts

• Adaptability to shifting priorities, regulatory expectations, and business needs