Manager, Quality Systems 503B - East Windsor, NJ

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 three core values: People, Quality and Service. 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.  

The Manager of Quality Systems is a key role in ensuring the integrity and continuous improvement of Empower Pharmacy's quality management processes. This position is essential to maintaining compliance with Good Manufacturing Practices (GMP) and ensuring that the company meets its quality objectives. The Manager is responsible for implementing and enhancing quality systems, including managing audits, handling corrective and preventive actions (CAPA), and overseeing nonconformance investigations. This role directly aligns with Empower’s commitment to people, service, quality, and innovation, by ensuring the highest standards in product quality and regulatory compliance.

This role involves leading internal audits, managing supplier audits, and supporting various quality initiatives, such as change control and risk management. The Manager will work cross-functionally, serving as a technical liaison on quality matters and representing the Quality Department during regulatory inspections and client audits. They will also review and approve change control projects, develop implementation plans, and write or revise Standard Operating Procedures (SOPs) to reflect changes in processes and improvement programs.

The Manager, Quality Systems, plays a pivotal role in analyzing quality data to proactively address potential issues, reducing waste, and ensuring continual improvement in product quality. By providing leadership in compliance, risk management, and regulatory adherence, this position supports Empower’s mission of expanding access to high-quality, affordable medication.

If you are passionate about quality systems and compliance and want to contribute to a mission-driven company that produces innovative medications to improve people’s lives, we encourage you to apply and become part of Empower Pharmacy’s vision for a healthier, happier world.

• Manages the implementation and improvement of Quality Systems based on established direction and priorities.
• Leads, supports, and performs activities in Internal Quality Audits, Supplier Audits, CAPA, Nonconformance Investigations, Quality Management Reviews, Document Control, Change Control, Risk Management, and Training.
• Establishes and maintains a continuous improvement program.
• Assists with Training on good documentation practices/GMP and other quality-related topics.
• Ensures compliance with quality policies, procedures, and governing regulations.
• Represents Quality Department during regulatory inspections, client audits and various cross-functional meetings, as needed.
• Reviews and approves change control, improvement programs and projects.
• Develops implementation plans to attain the approved change and projects.
• Writes, reviews and revises SOPs and related documentations to align with change control, improvement programs and other projects.
• Examines quality resources to proactively identify potential issues affecting the quality of the finished product and facilitate continual improvement.
• Serves as technical liaison regarding quality matters.
• Compiles and reports key performance indicators, metrics, and compliance status of Quality Systems for Management Review.
• Collects trends and analyzes data to lead quality unit to proactive quality and minimize waste.
• Responds to and investigates nonconformity events.
• Examines incidents and their potential impact on business.
• Conducts internal audits.
• Provides exceptional customer service to Empower Pharmacy’s internal and external customers in all assigned tasks and fosters a GMP compliance culture.
• Performs other duties as assigned.

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.

• Working knowledge of sterile aseptic manufacturing is required.
• Working knowledge of pharmacy and current GMP regulations including current United States Pharmacopeia <795>, <797>, <800>, 21 Code of Federal Regulations Part 210, 211 and Part 11-Electronic Records required.
• International regulation and guidance knowledge/experience preferred (i.e., European Union, International Council for Harmonisation, Canadian GMPs).
• Good organizational and leadership skills, elevated level of attention to detail, excellent oral and written communication skills with the ability to effectively interact at all levels.
• Skilled in the application of continuous process improvement tools (e.g., six sigma, lean manufacturing).

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.

• Bachelor’s Degree in a technical (Natural Sciences or Engineering) field required with a Master’s Degree preferred.
• Minimum 5 years of experience in the pharmaceutical industry required.
• Minimum 5 years of experience in root cause analysis required.
• Experience in performing compliance system enhancements preferred.
• Experience in leading cross functional teams, propelling change and driving projects to completion.

• No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
• Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
• Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
• Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
• Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
• Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
• FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
• Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
• Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
• Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.

Additional Voluntary Benefits

• Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
• Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
• Critical Illness: Protect your finances from the expenses of a serious health issue.
• Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
• Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
• Legal Services: Access professional legal assistance to address concerns confidently.
• Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
• Pet Insurance: Care for your furry family members with our pet insurance coverage.
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.