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- Tasks: Lead the Quality team to ensure compliance and drive continuous improvement in a dynamic environment.
- Company: Join Perspective Therapeutics, a leader in radiopharmaceuticals with a commitment to quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Work in a collaborative culture focused on innovation and safety.
- Why this job: Make a real impact on patient safety and product quality in a cutting-edge industry.
- Qualifications: 7+ years in Quality roles, preferably in pharmaceuticals or radiopharmaceuticals.
The predicted salary is between 70000 - 90000 £ per year.
We are seeking a Sr. Manager to serve as the site Quality leader who supports and helps execute Perspective Therapeutics’ Somerset, NJ Quality Management System (QMS), with primary accountability for site-level quality performance, ensuring that the system and site operations are compliant with applicable regulations, standards, and company requirements. This experienced people leader and subject matter expert provides day-to-day leadership to the Somerset Quality Team (Quality Assurance, Quality Control, and Microbiology), sets quality priorities and direction for the site, partners with site leadership, and supports the Quality Leadership Team in achieving near- and long-term strategic objectives aligned with quality requirements.
The Sr. Manager, Quality champions a sustainable quality culture of continuous improvement, ensures senior management and corporate Quality leadership are informed of site quality performance, risks, and improvement needs, and applies sound judgment and practical, on-the-floor problem solving to support safe, compliant manufacturing. This individual proactively assesses and manages quality and compliance risks, particularly those related to radiopharmaceutical and aseptic product requirements and drives timely, effective, and durable corrective and preventative actions.
Essential Functions- Serve as the primary site Quality representative and decision-maker on routine quality matters, representing Perspective Therapeutics in interactions with suppliers, third-party partners, and internal stakeholders; independently resolves issues within delegated authority and escalates risks appropriately.
- Provide visible leadership and strategic guidance to strengthen a quality culture of continuous improvement and safety across the organization through further clinical development and commercialization of radiopharmaceutical products.
- Direct, mentor, and develop Quality Assurance, Quality Control, and Microbiology staff through hands-on coaching, clear performance expectations, succession planning, and active presence in operations.
- Support hiring, onboarding, training, and performance management processes to ensure team competencies, capabilities, and capacity to meet business goals and expectations.
- Partner cross-functionally with Production, Safety, R&D, Operations, Program Management, and other functional areas to ensure compliant execution of procedures, robust documentation practices, and effective resolution of quality issues.
- Oversee batch release process, ensuring products are manufactured and tested in accordance with all applicable regulations, standards and procedures.
- Ensure the proper performance of Perspective Therapeutics’ QMS, including site quality audit program and follow-up of audit outcomes.
- Demonstrate management-level communication skills, with the ability to influence, align, and build trust across all organizational levels.
- Maintain availability to work outside of regular business hours and provide on-site and/or remote support for night shift operations on an as-needed basis.
- Ensure annual GxP training requirements are met (including GMP, GCP, GDP, and GLP) and assess the effectiveness of training programs.
- Provide oversight of product and process investigations, deviations, and CAPA management to ensure timely resolution of issues and prevention of recurrence.
- Own site-level metrics and performance monitoring, including tracking and trending internal and external manufacturing quality data; interpret trends, present insights to management, and drive improvement initiatives.
- Establish testing protocols and ensure all third-party testing is conducted in a timely manner at qualified vendors and according to approved protocols.
- Maintain facility licenses and registrations for manufacturing requirements.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience- A bachelor’s degree (or higher) in scientific discipline is required.
- Minimum of 7 years’ applicable experience with Radiopharmaceuticals/Pharmaceuticals in a Quality role, with at least 3 years in a supervisory and/or site quality leadership capacity.
- Experience in oversight of sterile drug development/manufacture, preferably aseptic products.
- Experience in interpreting and applying regulatory requirements applicable to Radiopharmaceuticals preferred.
- Demonstrated experience serving as a quality lead for a manufacturing site, program, or major functional area.
- Experience in hosting and responding to regulatory audits.
- Comprehensive knowledge of manufacturing license regulations in New Jersey.
- Strong knowledge of 21 CFR Parts 11, 58, 210, 211, 212, 312, EU GMP (Annex 1) and others.
- Strong knowledge of ICH guidelines and aseptic practices.
- Knowledge of global regulatory requirements, including PIC/S.
- Knowledge of radiation diagnostic and therapy products.
- Strong knowledge of regulatory requirements for US, EU, and other global markets.
- Proven ability to exercise independent judgment, make risk-based decisions, and accept accountability for outcomes.
- Ability to work under pressure and multi-task; flexibility to handle a variety of projects and shifting priorities.
- Availability to support off-shift operations (including night shift) on an as-needed basis.
- Ability to research, interpret, understand and explain requirements of future business growth opportunities.
- Excellent problem solving, investigations, interpersonal and communication (verbal and written) skills.
- Strong management skills with experience meeting tight timelines and preparing budgets.
- Strong leadership skills with the ability to positively motivate a team.
- Hands-on leadership style with the ability to be present in the manufacturing environment, coach in real time, and drive timely resolution of quality issues.
- Ability to identify, communicate and mitigate operational risks.
- Ability to travel up to 10%.
The work environment characteristics described here are representative of those an employee encounters performing the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
- Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
- May be required to sit or stand for long periods of 8+ hours a day while performing duties. Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
- 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 radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
- Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
Sr. Manager, Quality in Somerset employer: Perspective Therapeutics
Contact Detail:
Perspective Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. Manager, Quality in Somerset
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their quality management system and think about how your experience aligns with their needs. We want you to walk in feeling confident and ready to impress!
✨Tip Number 3
Showcase your leadership skills during interviews. Talk about how you’ve mentored teams and driven quality improvements in past roles. We’re looking for someone who can inspire and lead, so let that shine through!
✨Tip Number 4
Don’t forget to follow up after your interviews! A quick thank-you email can go a long way in keeping you top of mind. We appreciate candidates who show enthusiasm and professionalism, so make sure to express your interest in the role.
We think you need these skills to ace Sr. Manager, Quality in Somerset
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in quality management, especially in the radiopharmaceutical sector. We want to see how your skills align with our needs!
Showcase Leadership Skills: As a Sr. Manager, you'll be leading a team, so don’t forget to emphasise your leadership experience. Share examples of how you've mentored others and driven a culture of continuous improvement.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so make sure your key achievements and qualifications stand out without unnecessary fluff.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Perspective Therapeutics
✨Know Your Quality Management Systems
Make sure you brush up on your knowledge of Quality Management Systems, especially those relevant to radiopharmaceuticals. Be ready to discuss how you've implemented or improved QMS in your previous roles, as this will show your expertise and readiness for the position.
✨Demonstrate Leadership Experience
Prepare examples that showcase your leadership skills, particularly in managing teams in a quality environment. Think about specific situations where you mentored staff or led initiatives that improved quality culture, as this aligns perfectly with what they’re looking for.
✨Understand Regulatory Requirements
Familiarise yourself with the regulatory landscape, including 21 CFR Parts and ICH guidelines. Be prepared to discuss how you've navigated these regulations in past roles, as this will demonstrate your capability to manage compliance effectively.
✨Showcase Problem-Solving Skills
Think of concrete examples where you’ve tackled quality issues head-on. Highlight your problem-solving process and the outcomes, as this will illustrate your ability to handle challenges and drive continuous improvement in a quality setting.