Quality Assurance Manager

Job Description

Job DescriptionJob Title: QA Manager – Radiopharmaceutical Manufacturing
Job Description

The QA Manager oversees quality assurance operations in a radiopharmaceutical manufacturing facility, ensuring that product performance and quality consistently meet established standards and regulatory guidelines. This role provides expert guidance on governmental regulations, agency expectations, and internal policies, and partners closely with cross-functional teams to maintain a robust quality operations platform. The QA Manager leads inspections and audits, drives continuous improvement, and builds a high-performance team culture focused on accountability, transparency, and exceptional customer service.

Responsibilities

• Manage all aspects of plant Quality Operations, with a strong floor-level presence and direct support for focus factory quality engineering activities.
• Maintain operational compliance with US and international regulatory agencies and guidelines, including FDA, EU, Health Canada (HC), TGA, PIC/S, ISO, USP, NRC, and cGMP requirements.
• Establish, implement, and maintain appropriate quality systems, including ongoing data analysis of product and process outputs to detect and respond early to quality concerns and prevent quality issues.
• Ensure compliance with cGMPs, good housekeeping practices, employee hygiene standards, and equipment sanitation requirements.
• Analyze plant errors and process statistics to identify significant trends, findings, and conclusions, and implement corrective and preventive actions as needed.
• Collaborate with Research and Development during new product start-ups and establish key checkpoints for new products and processes.
• Make fact-based, scientifically sound quality decisions regarding products manufactured at the facility.
• Ensure that process, equipment, and facility validations meet expectations for validation standards, process capability, corrective actions, and general compliance with applicable regulatory agencies.
• Support and promote an aggressive quality program that instills personal accountability for accuracy, consistency, and completeness across all operations and departments.
• Create and maintain an environment of excellence, world-class quality, and continuous improvement throughout the entire plant.
• Hire, lead, and manage departmental personnel directly and through subordinate leaders, ensuring appropriate staffing, development, and performance management.
• Coach and develop the quality team to high performance while fostering a culture of ownership, accountability, and collaboration.
• Ensure team compliance with all corporate and local policies, procedures, and site regulations.
• Set a clear vision for the department by aligning goals and objectives with site strategies and managing each team member’s performance against those goals.
• Exhibit accountability and responsibility for assigned areas or processes, leading change initiatives and driving ideas through to completion.
• Provide leadership for employee relations through effective communication, coaching, training, and development, removing roadblocks so the team can progress.
• Deliver the highest level of internal and external customer service while constructively and diplomatically challenging established procedures and systems when improvement is needed.
• Educate the team on the business and financial impact of quality decisions and actions, providing ongoing feedback and context.
• Ensure all direct reports maintain ALARA (As Low As Reasonably Achievable) principles and manage their daily activities to meet quarterly ALARA goals.
• Hold regular team meetings to update staff, communicate priorities, and track progress against objectives.
• Lead and actively participate in continuous improvement activities, incorporating team input and maintaining control and focus when faced with adversity.
• Ensure proper maintenance and cleanliness of the department, premises, and equipment to support quality and safety standards.
• Measure and communicate the team’s progress against individual, team, and site goals and Key Performance Indicators (KPIs).
• Recognize and reward strong performance to reinforce desired behaviors and outcomes.
• Lead and/or support quality and safety investigations, and author, review, and approve area quality and safety exceptions and investigation reports.
• Ensure on-time completion of all corrective and preventive action items assigned to the area.
• Identify and drive opportunities to reduce costs, mitigate risk, and improve service levels across quality operations.
• Work a typical schedule of Monday through Friday, 7:00 a.m. to 4:00 p.m., with flexibility to work outside regular hours as business needs require.

Essential Skills

• Bachelor’s degree in Physical Science, Chemistry, or Life Science is required; a Master’s degree is preferred.
• 12 or more years of multi-functional Quality experience, including Quality Assurance, with at least 2 years in a leadership role, preferably managing a team of degreed professionals.
• Expert knowledge of cGMP requirements, specifically within the pharmaceutical and/or chemical industries.
• Strong working knowledge of US and international regulatory requirements and guidance documents relevant to pharmaceutical and radiopharmaceutical manufacturing.
• Complete understanding and practical application of principles, concepts, practices, and standards for testing performed in Quality Control (QC) laboratories.
• Thorough understanding of quality systems and their implementation in a regulated manufacturing environment.
• Ability to use relevant software packages to process and analyze data, with a high level of proficiency in Microsoft Windows and Office Suite (Word, Excel, PowerPoint, and Access).
• Advanced computer skills to support data analysis, documentation, and reporting.
• Excellent verbal and written communication skills, with the ability to communicate clearly across all levels of the organization.
• Strong interpersonal skills and a team-oriented mindset, with the ability to build and maintain positive working relationships.
• Proven ability to coach, mentor, and teach team members to enhance performance and capability.
• Demonstrated decision-making, problem-solving, and analytical skills in a complex, regulated environment.
• Ability to act as a change agent and positively influence stakeholders at all levels of the organization.
• High attention to detail and accuracy, with the ability to work effectively under tight deadlines.
• Ability to manage multiple priorities simultaneously in a fast-paced environment.
• Strong conflict management skills and the ability to navigate and resolve issues constructively.
• Demonstrated learning agility and openness to change, with the ability to adapt to evolving requirements.
• Effective time management skills to plan, prioritize, and execute work efficiently.
• Technical writing skills for authoring, reviewing, and approving procedures, investigation reports, and other quality documentation.
• Experience with developing and documenting procedures in a regulated environment.

Additional Skills & Qualifications

• Master’s degree in a related scientific discipline is preferred and considered an asset.
• Lean, Kaizen, or Six Sigma experience is preferred, particularly in driving continuous improvement and waste reduction.
• Experience in radiopharmaceutical, pharmaceutical, or chemical manufacturing environments is highly beneficial.
• Experience leading or supporting regulatory inspections and internal or external audits.
• Proven ability to interpret and apply guidance from agencies such as FDA, EU authorities, Health Canada, TGA, PIC/S, USP, and NRC.
• Demonstrated ability to build a culture of accountability, transparency, and high performance within a quality-focused team.
• Ability to clearly explain complex quality and regulatory concepts to non-specialists.
• Strong facilitation skills for leading meetings, training sessions, and cross-functional initiatives.
• Comfort working with and analyzing large data sets to identify trends, risks, and improvement opportunities.

Work Environment

This role is based in a manufacturing plant that produces radioactive materials and operates under strict safety and regulatory standards. All employees participate in comprehensive safety programs designed to minimize potential and actual exposure levels, including adherence to ALARA principles. The position typically follows a Monday through Friday schedule from 7:00 a.m. to 4:00 p.m., but may require work outside regular hours, including off-shift, weekend, and holiday work, depending on business needs. The work involves both office-based tasks and time on the production floor, with regular exposure to mechanical and moving parts and to industrial environments where corrosive, flammable, and toxic materials, as well as dust, dirt, odors, and irritants, may be present. Employees must be able to work indoors and outdoors as required. The physical demands of the role include the ability to lift up to 70 pounds; kneel, crouch, twist the upper body, walk, bend, stoop, push, pull, and reach; and physically negotiate stairs and evacuation ladders with or without accommodation. The role may require entering vessels and inspecting equipment in confined or challenging spaces. Material handling devices such as hand trucks, fork trucks, and conveyors are used when possible, but proper lifting and movement techniques remain essential to prevent injury. The position requires the ability to wear and operate various types of safety equipment and personal protective equipment (PPE), including hearing protection, as needed. Employees may be required to sit or stand for extended periods of 8 or more hours per day while performing duties and must possess good hand-eye coordination and close attention to detail. Completion of required safety training within specified timeframes is mandatory. The work culture emphasizes teamwork, open communication, continuous improvement, and a strong commitment to safety and quality in all activities.

Job Type & Location

This is a Permanent position based out of Maryland Heights, MO.

Pay and Benefits

The pay range for this position is $125000.00 - $130000.00/yr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Maryland Heights,MO.

Application Deadline

This position is anticipated to close on Apr 16, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.