Director, Quality 503b

2 weeks ago

East Windsor, United States Empower Pharmacy Full time

Position Summary:
As the Director, Quality 503B at Empower, you will be a cornerstone of our commitment to excellence in pharmaceutical manufacturing. Your role is vital in maintaining the integrity of our drug preparation processes and ensuring compliance with stringent government regulations and standards for current Good Manufacturing Practices (cGMPs) and the Food and Drug Administration’s (FDA) Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B. By directing and monitoring quality standards, you will safeguard and reinforce our mission to provide innovative, high-quality medications that improve the health and well-being of our customers.

In this leadership position, you will oversee daily operational tasks such as batch record creation, review, materials testing, and release, ensuring that our manufacturing processes are error-free and efficient. You will spearhead investigative teams to reduce quality waste and drive operational excellence. Your expertise will be pivotal in developing and managing the Quality Assurance (QA), Quality Control (QC), On-the-Floor Quality, Visual Inspection and Labeling, and internal analytical lab departments.

Collaboration and continuous improvement are at the heart of this role. You will lead Non-Conformance Incidents (NCIs), Deviations, and corrective and preventative actions (CAPA) Investigations, providing analytical analysis for root cause issues. Your responsibility extends to reviewing and driving departmental policies and procedures to keep Empower at the forefront of the pharmaceutical industry.

Duties and Responsibilities:

- Directs, monitors, and ensures quality standards and drug preparation process complies with government regulations and standards for cGMPs and/or FDA’s Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B.
- Responsible for directing the teams responsible for batch record creation, review, materials testing and release.
- Provides quality leadership to reduce errors and defects throughout the manufacturing facility.
- Leads investigative teams to drive down quality waste and assist with operational excellence.
- Develops, directs, and manages the QA, QC, On-the-Floor Quality, Visual Inspection and Labeling, and internal analytical lab.
- Oversees the drafting, review, approval, distribution, and maintenance of the following: (1) aseptic technique qualifications and media fill process, (2) and equipment and process validations, (3) operating procedures and specifications, (4) routine change control requests as designated and leads the change control program, (5)raw materials specification limits.
- Leads NCIs, deviations and CAPA Investigations.
- Assists with the analytical analysis for root cause issues.
- Enters cleanroom and manufacturing space frequently and upon critical incidents to assist with investigations (must be able to gown qualify).
- Reviews test results and inputssummaries into the monthly and quarterly QA report templates.
- Ensures quality records are maintained (equipment calibration and maintenance, training, deviation, and complaint investigations).
- Leads with drafting and execution any of the above responsible duties in the case of absence or vacancy.
- Stays informed of industry trends, regulatory changes, and best practices and makes relevant updates to departmental policies and procedures.
- Monitors department performance through key performance indicators and operational metrics to track progress and make data-driven decisions.
- Provides leadership, guidance, and mentorship to quality assurance, fostering a culture of collaboration, accountability, innovation, and continuous improvement.
- Completes and communicates annual performance evaluations and provides coaching and feedback to direct reports, recognizing achievements and addressing areas for improvement as needed.
- Evaluates department headcount needs and actively participates in interview, selection, and onboarding of new employees.
- Provides leadership during regulatory inspections.
- Performs other QA/Regulatory duties as assigned.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

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 occasionally required to stand, walk, reach with arms and h

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