Empower Pharmacy
Join to apply for the
Manager, Quality Operations
role at
Empower Pharmacy Join to apply for the
Manager, Quality Operations
role at
Empower Pharmacy Location:
East Windsor, New Jersey 08520, United States
Posted:
May 14, 2025
Job Type:
FULL TIME
Req#
4374
Quality
Company Overview
Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.
What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.
You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.
Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.
Position Summary
The Manager, Quality Operations ensures high standards in Empower’s aseptic filling and finishing operations, leading the quality assurance team to drive first-time right processes and compliance. This role optimizes batch release, investigates deviations, and fosters continuous improvement to support Empower’s mission of delivering innovative, high-quality medications
Duties And Responsibilities
Leads the quality assurance team in aseptic sterile filling and finishing operations to ensure on-the-floor quality and first-time right processes. Manages the batch release team, ensuring compliance with documentation, procedures, and regulations, and optimizing the batch release process to meet cycle time goals. Oversees the training and cross-training of Quality Operations staff, ensures compliance with sterility testing, aseptic techniques, and media fill process validations, and serves as a subject matter expert in the preparation and revision of procedures. Drives continuous improvement by implementing streamlined processes in compounding, validation, and risk assessments, and utilizes Corrective and Preventive Actions (CAPA) to resolve issues and enhance quality. Manages investigations into deviations, complaints, and manufacturing excursions, ensuring compliance with standards, and maintains quality records for ongoing audits and reviews.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
Knowledge And Skills
Demonstrates strong leadership, effective communication, and organizational skills, with the ability to work both autonomously and as part of a team to resolve problems. Possesses in-depth knowledge of pharmaceutical manufacturing, United States Pharmacopeia , current good manufacturing practices, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations, with proficiency in computer software, particularly SharePoint.
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions. Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement. Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives. Resourcefulness: Secures and deploys resources effectively and efficiently. Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems. Ensures Accountability: Holds self and others accountable to meet commitments and objectives. Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations. Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Values
People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce. Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service. Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
Experience and Qualifications
Minimum of 7 years of experience in pharmaceutical quality, including 3 years in a supervisory role, with experience in international regulatory agencies highly desirable. Bachelor of Science degree in a technical or scientific discipline with 7 years of experience in pharmaceutical quality, including at least 3 years in a supervisory role, or a minimum of 10 years of experience in pharmaceutical quality, including at least 3 years in a supervisory role. Preferred American Society for Quality (ASQ) certifications, such as Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or Software Quality Assurance Registered Quality Assurance Professional. Demonstrated experience leveraging AI in daily work to drive efficiency, solve problems, and enhance decision-making—adept at integrating AI-powered solutions into all workflows.
Employee Benefits, Health, and Wellness
We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/ Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Empower Pharmacy by 2x Sign in to set job alerts for “Quality Operations Manager” roles.
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Manager, Quality Operations
role at
Empower Pharmacy Join to apply for the
Manager, Quality Operations
role at
Empower Pharmacy Location:
East Windsor, New Jersey 08520, United States
Posted:
May 14, 2025
Job Type:
FULL TIME
Req#
4374
Quality
Company Overview
Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.
What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.
You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.
Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.
Position Summary
The Manager, Quality Operations ensures high standards in Empower’s aseptic filling and finishing operations, leading the quality assurance team to drive first-time right processes and compliance. This role optimizes batch release, investigates deviations, and fosters continuous improvement to support Empower’s mission of delivering innovative, high-quality medications
Duties And Responsibilities
Leads the quality assurance team in aseptic sterile filling and finishing operations to ensure on-the-floor quality and first-time right processes. Manages the batch release team, ensuring compliance with documentation, procedures, and regulations, and optimizing the batch release process to meet cycle time goals. Oversees the training and cross-training of Quality Operations staff, ensures compliance with sterility testing, aseptic techniques, and media fill process validations, and serves as a subject matter expert in the preparation and revision of procedures. Drives continuous improvement by implementing streamlined processes in compounding, validation, and risk assessments, and utilizes Corrective and Preventive Actions (CAPA) to resolve issues and enhance quality. Manages investigations into deviations, complaints, and manufacturing excursions, ensuring compliance with standards, and maintains quality records for ongoing audits and reviews.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
Knowledge And Skills
Demonstrates strong leadership, effective communication, and organizational skills, with the ability to work both autonomously and as part of a team to resolve problems. Possesses in-depth knowledge of pharmaceutical manufacturing, United States Pharmacopeia , current good manufacturing practices, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations, with proficiency in computer software, particularly SharePoint.
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions. Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement. Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives. Resourcefulness: Secures and deploys resources effectively and efficiently. Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems. Ensures Accountability: Holds self and others accountable to meet commitments and objectives. Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations. Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Values
People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce. Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service. Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
Experience and Qualifications
Minimum of 7 years of experience in pharmaceutical quality, including 3 years in a supervisory role, with experience in international regulatory agencies highly desirable. Bachelor of Science degree in a technical or scientific discipline with 7 years of experience in pharmaceutical quality, including at least 3 years in a supervisory role, or a minimum of 10 years of experience in pharmaceutical quality, including at least 3 years in a supervisory role. Preferred American Society for Quality (ASQ) certifications, such as Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or Software Quality Assurance Registered Quality Assurance Professional. Demonstrated experience leveraging AI in daily work to drive efficiency, solve problems, and enhance decision-making—adept at integrating AI-powered solutions into all workflows.
Employee Benefits, Health, and Wellness
We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/ Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Empower Pharmacy by 2x Sign in to set job alerts for “Quality Operations Manager” roles.
Cranbury, NJ $143,000.00-$214,000.00 6 days ago East Windsor, NJ $100,000.00-$120,000.00 4 months ago Perth Amboy, NJ $73,440.00-$95,000.00 5 days ago Bristol, PA $85,000.00-$100,000.00 4 days ago Monroe, NJ $80,000.00-$100,000.00 2 weeks ago North Brunswick, NJ $100,000.00-$130,000.00 1 week ago Bridgewater, NJ $111,000.00-$156,133.00 3 days ago New Brunswick, NJ $70,920.00-$117,990.00 3 months ago Burlington, NJ $108,000.00-$178,600.00 2 days ago Supply Chain & Logistics Supervisor - 2nd Shift
Assurance Manager, Quality Management - IS Assurance
Woodbridge, NJ $100,000.00-$150,000.00 1 hour ago Cranbury, NJ $90,000.00-$150,000.00 1 week ago Perth Amboy, NJ $65,000.00-$75,000.00 1 week ago Perth Amboy, NJ $65,000.00-$75,000.00 1 week ago Perth Amboy, NJ $65,000.00-$75,000.00 1 week ago Histotechnology Supervisor - Hamilton, NJ
Hamilton Township, NJ $90,000.00-$110,000.00 3 days ago New Brunswick, NJ $83,200.00-$156,000.00 2 weeks ago Lakewood, NJ $125,000.00-$160,000.00 1 month ago Lumberton, NJ $43,888.00-$93,574.00 9 hours ago Automotive Store Manager (Weekly Pay + Monthly Bonuses!!!)
New Brunswick, NJ $80,000.00-$110,000.00 1 week ago Project Managers, Operations Managers, COE Managers, & General Managers
Old Bridge, NJ $63,300.00-$91,700.00 2 weeks ago Jackson, NJ $63,300.00-$91,700.00 1 week ago New Brunswick, NJ $85,000.00-$124,000.00 4 hours ago Monmouth County, NJ $70,200.00-$159,171.19 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr