Director, Quality Operations 503B - Houston, TX - Empower Pharmacy

Position Summary:

The Director of Quality Operations plays a pivotal role in ensuring Empower Pharmacy's commitment to excellence in manufacturing. This position is integral to upholding our values of people, service, quality, and innovation. By directing the teams responsible for batch record creation, materials testing, and quality systems, this leader ensures that our products consistently meet the highest standards, enhancing patient care and satisfaction.

 

In this site leadership role, you will provide quality leadership to reduce errors and defects across the manufacturing facility, leading investigative teams to drive operational excellence and minimize waste. You will oversee the drafting, review, approval, and maintenance of critical quality documents, including aseptic technique qualifications, equipment validations, and operating procedures. Your expertise will be crucial in leading non-conformance investigations, deviations, and corrective action, preventative action (CAPA) processes, ensuring that root cause analyses are thorough and corrective actions are effective.

 

Additionally, you will be a hands-on site leader, frequently entering cleanroom and manufacturing spaces to assist with investigations and ensure compliance. You will review test results and compile comprehensive quality assurance reports, maintaining meticulous records of equipment calibration, maintenance, and training. By partnering with Quality Assurance, you will stay informed of industry trends and regulatory changes, updating departmental policies and procedures accordingly. Your leadership will be vital in monitoring department performance through key performance indicators (KPIs) and operational metrics, fostering a culture of collaboration, accountability, and continuous improvement.

 

We invite you to join our mission of producing innovative medications that help people live happier, healthier lives and expand access to quality, affordable medication. If you are passionate about quality and eager to lead a dedicated team towards operational excellence, we encourage you to apply for this exciting opportunity at Empower Pharmacy. Together, we can make a meaningful difference in the lives of patients and communities we serve.

Duties and Responsibilities:

• Oversees teams dedicated to batch record creation and review, materials testing and release, on-floor quality assurance, quality systems management, and laboratory operations (where applicable).
• Leads quality initiatives such as developing and enforcing robust quality control procedures, training, and mentoring staff on quality standards, utilizing data-driven approaches to identify and address root causes of quality issues.
• Leads investigative teams to drive down quality waste and assist with operational excellence.
• Oversees the drafting, review, approval, distribution and maintenance of aseptic technique qualifications and media fill process, equipment and process validations, operating procedures and specifications, routine change control requests as designated and leads the change control program, and raw materials specification limits.   
• Leads Non-Conformance Investigations, deviations, and CAPA investigations by identifying root causes, developing comprehensive action plans, and ensuring timely resolution and implementation.
• Assists with the analytical analysis for root cause issues ensuring a comprehensive understanding of the underlying causes and supports the implementation of corrective actions to prevent future occurrences.
• Frequently enters cleanroom and manufacturing spaces, particularly during critical incidents, to assist with investigations and ensure timely resolution of quality issues.
• Reviews test results and compiles summaries for inclusion in monthly and quarterly Quality Assurance report templates.
• Ensures quality records are maintained including documentation for equipment calibration and maintenance, training, deviation, and complaint investigations. 
• Partners with Quality Assurance to stay informed of industry trends, regulatory changes, and best practices and makes relevant updates to departmental policies and procedures.
• Monitors department performance through KPIs and operational metrics to track progress and make data-driven decisions. 
• Provides leadership, guidance, and mentorship to quality operations, 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 support during regulatory inspections.
• Other 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 accommodation 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 hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Must have the ability to properly gown in aseptic PPE to enter a sterile manufacturing environment.

Knowledge and Skills:

• In-depth knowledge of cGMP, Food Drug Administration regulations (21 CFR Parts 210, 211), Internal Conference on Harmonization regulations and United Stated Pharmacopeia.
• Ability to work autonomously within established procedures and practices.   
• Leadership skills and the ability to facilitate the work activities of others.   
• Proficiency with computer software, Microsoft Office preferred.   
• Good organizational and time management skills.  

 

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.

Experience and Qualifications:

• Bachelor’s degree in Scientific or Technical discipline from an accredited institution required.
• Minimum 10 years of experience in 503A and/or 503B pharmaceutical compounding, including sterile, aseptic operations.
• Minimum 2 years of experience in a quality leadership position, leading and participating in regulatory inspections.
• Minimum 5 years required experience with injectables (mix, wash, depyrogenation, fill-finish).
• Experience with non-sterile operations and terminal sterilization of finished goods preferred.
• 21 CFR experience required; European Union Annex 1 preferred.   
• Experience with international regulatory agencies with thorough knowledge of pharmaceutical manufacturing/controls and current good manufacturing practices (cGMP).  

Benefits:

• 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.