Sr. Director of Quality- RX

Job Title: Senior Director of Quality

Location: Houston, TX 

Job Type: Full-Time

About Revive Rx Pharmacy: Revive Rx Pharmacy, a frontrunner in the pharmaceutical industry, is known for its commitment to exceptional quality and customer service. We are in search of an experienced and visionary Senior Director of Quality to lead our quality assurance and regulatory compliance initiatives.

Job Overview: The Senior Director of Quality at Revive Rx Pharmacy will be responsible for setting the strategic direction of our quality assurance programs. This executive role involves overseeing Quality Records Events (QRE), managing customer complaint resolution processes, and leading the development and implementation of comprehensive Corrective and Preventive Action (CAPA) plans. The ideal candidate will bring a proactive leadership approach to quality management, ensuring our products and services consistently exceed regulatory standards and customer expectations.

Key Responsibilities:

1. Strategic Oversight of Quality Records Events (QRE):

   • Provide strategic leadership in identifying, documenting, and analyzing Quality Records Events.
   • Develop and implement advanced processes for efficient and accurate recording of quality incidents, setting industry standards.

2. Leadership in Customer Complaints Resolution:

   • Oversee the customer complaint process, ensuring efficient, thorough information gathering and documentation.
   • Lead in-depth investigations in collaboration with cross-functional teams to determine root causes.
   • Develop and enforce corrective and preventive measures, elevating customer satisfaction and product quality.

3. CAPA Plan Development and Implementation:

   • Design, implement, and oversee comprehensive Corrective and Preventive Action plans, setting benchmarks for quality improvements.
   • Ensure effective execution and cross-departmental collaboration in CAPA plan implementation.
   • Regularly evaluate the impact and efficacy of CAPA initiatives, driving continuous improvement.

4. State Licensure Compliance Management:

   • Direct the management of state licensure requirements, ensuring all practices are compliant with current regulations.
   • Stay abreast of regulatory changes, leading the adaptation of strategies to maintain compliance.

5. Expertise in State Board of Pharmacy Correspondence:

   • Act as the senior liaison for all communications with state boards of pharmacy.
   • Foster a deep understanding of state pharmacy regulations, ensuring organizational alignment with legal requirements.

Preferred Qualifications:

• Over 5 years of executive experience in a similar role, preferably in a 503B environment.
• Extensive expertise in quality management, customer complaint resolution, and regulatory compliance in the pharmaceutical sector.
• Profound knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulations.
• Exceptional leadership, strategic thinking, problem-solving, and communication skills.
• A strong commitment to quality, attention to detail, and a track record of driving continuous improvement in quality standards.