Manager Quality Assurance

Summary of Position

The Manager of Quality Assurance in our radiopharmaceutical manufacturing facility will maintain a quality operations platform, ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to ensure compliance. Work directly with internal operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

Establish and ensure appropriate Quality are maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns and prevention of quality issues. Establish and ensure compliance with cGMPs, good housekeeping practices, employee hygiene and equipment sanitation; analyze plant error and process statistics for significant findings and conclusions; work with Research and Development during new product start-ups and establish key checkpoints for new products and processes.

The Manager of Quality Assurance is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within their team while ensuring information is timely, clear and accurate. By coaching and developing the team to High Performance will foster a team ownership culture that ensures compliance with all Corporate and Local policies, procedures and regulations. In addition, must supply the highest level of both internal and external customer service. To effectively recognize and reward performance, the Manager must measure and communicate the team’s progress against individual, team and site goals and Key Performance Indicators (KPIs).

Schedule: Monday – Friday 7am – 4pm 

Essential Functions

• Manage all aspects of plant Quality Operations for floor level focus factory quality engineer support. 
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Hire and manage departmental personnel directly and through subordinate leaders.
• Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies.
• Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant.
• Responsible for making fact-based, scientifically sound, quality decisions regarding products manufactured at the Maryland Heights facility.
• Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance for applicable regulatory agencies.
• Ensure accountability, transparency, and effective communication cross-functionally and within the team while ensuring information is timely, clear and accurate.
• Coach and develop the team to High Performance while fostering a culture of team ownership.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
• Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.
• Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward.
• Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
• Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.
• Ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
• Hold regular team meetings to update team and track progress.
• Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
• Ensure proper maintenance and cleanliness of the department, premises and equipment.
• Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPIs).
• Recognize and reward performance.
• Lead and/or support investigations. Author, approve and/review area quality and safety exceptions and investigation reports.
• Ensure on-time completion of all corrective action items assigned to area.
• Identify opportunities to reduce costs, reduce risk and improve service.

Requirements

• Bachelor’s degree in Physical Science, Chemistry, or Life Science required, Master’s degree preferred
• 12 or more years of multi-functional Quality experience to include Quality Assurance, with 2 or more years in a leadership role(preferably managing a team of degreed professionals)
• Expert knowledge of cGMP requirements, specific to Pharmaceutical and/or Chemical industry experience required
• Complete understanding and application of principles, concepts, practices, and standards for testing performed in QC laboratories
• Strong working knowledge of US and international requirements and guidance documents.
• Thorough understanding of Quality systems
• Ability to use relevant software packages to process and analyze data.
• High level of proficiency in Microsoft Windows and Office Suite (Word, Excel, Power Point and Access), advanced computer skills
• Excellent communication and interpersonal skills
• Team orientation/strong team player
• Ability to coach, mentor and teach
• Excellent and proven decision making, problem solving and analytical skills
• Change agent with the ability to influence at all levels of the organization
• Detail-oriented with the ability to work under tight deadlines
• Ability to handle multiple priorities
• Excellent conflict management skills Learning/change agility
• Builds positive relationships with others
• Excellent time management skills
• Technical writing skills
• Lean / Kaizen / Six Sigma experience preferred
• Experience with developing/documenting procedures

Working Conditions: 

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. 
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.   
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. 
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. 
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.   
• Must possess good hand-eye coordination; close attention to detail is required. 
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.  
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment. 
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.