Why CorMedix? CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The company is focused on developing its lead product candidate DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. At CorMedix we are passionate about what we do each and every day! We provide comprehensive benefits and competitive compensation. If you are looking to join a team that puts the patient first and is changing the way that healthcare is delivered – let’s talk!
CorMedix is seeking a Director/Senior Director, Third Party Quality who will report to the Senior Vice President, Head of Global Quality. This hands-on role will be responsible for the Quality oversight monitoring of Third-Party Contractors, and other Quality Operations and Compliance activities that are expected in a commercial manufacturing environment. This role is accountable for the quality and compliance performance of third-party contractors, assuring that all GMP and CorMedix requirements are fully met.
The successful candidate is self-directed, has technical expertise in quality operations functions (including manufacturing processes and controls for aseptic products) and is comfortable using a risk-based approach with quality oversight activities. Excellent verbal and written communication skills, transparency in communication and the ability to build positive relationships with cross functional teams and external partners are key elements to being successful in this role. The successful candidate must have critical thinking skills, work effectively with cross functional partners and know how to overcome obstacles and deliver exceptional results in a very fast paced environment.
This is a remote based position, with occasional travel being required to our CorMedix office (located in Berkeley Heights, NJ), as needed.
Primary Responsibilities include:
Quality Oversight Monitoring of Third-Party Contractors:
The Director/Senior Director, Third Party Quality is responsible for the Quality Oversight Monitoring Program, which is intended to provide assurance of on-going GMP, quality and compliance performance at Third Party Contractors who support product development, manufacturing, packaging, testing, storage, and distribution for CorMedix owned products. This includes quality oversight of both drug substances (Active Pharmaceutical Ingredients) as well as finished drug products. Trending/reporting of defined key performance indicators (KPIs) is performed to assure overall performance is sustained at an acceptable level. If any emerging trends are identified, actions are taken to mitigate quality and compliance risks.
The Director/Senior Director, Third Party Quality is responsible for the procedures related to key quality activities and the direct execution of these activities. As the primary quality liaison with third party contractors, this role provides daily operational support and leverages technical expertise to assure non-conformances are properly handled and all quality and GMP requirements are met. This position also has the authority to make quality decisions for a wide variety of quality activities as noted below:
QA Review/Approval of:
· Master Batch Records, Specifications, Test methods
· Deviations, Non-Conformances, OOS (fully investigated, root causes identified)
· CAPAs (identified and implemented to mitigate risks, prevent potential for recurrence)
· Change Controls (properly justified/documented/approved, prior to implementation)
Final Quality Disposition / Final Market Release of finished goods:
· Assure the product was made in accordance with GMP requirements, results of all testing meet specification and all other quality requirements are met
· Review of executed batch records, test results, quality inspections, non-conformances, CoA, CofC, and all activities required for release
Post-Marketing Surveillance Activities:
· Review/approval of complaint investigations, stability commitments, APRs
· FDA reporting requirements (i.e., Field Alerts, Recalls)
· Routine surveillance, Due Diligence, For-Cause, or to meet business needs
· Supplier Qualification
o Product Development activities, Clinical Operations, API/material/component suppliers, CMO, CPO, Contract Laboratories, Contract Research Organizations
· Drive continuous improvement of the CorMedix Quality Management System and Quality
· 10 years or more QA experience in the pharmaceutical industry, including the following:
o Quality Management experience, that includes responsibility for Quality Operations, QA, QC, Regulatory Compliance functions, and quality systems
o Familiarity with regulatory compliance reporting requirements for post-marketing surveillance activities, including Product Quality Complaints, Field Alerts/Recall
o Knowledgeable about technical aspects of aseptic manufacturing processes related requirements
o Experience with quality oversight of third-party contractors (manufacturers, packagers, laboratories, warehouse/distribution)
· Bachelor’s Degree, in science related field such as Biology, Biotechnology, Chemistry
· Strong understanding of GXP requirements, including but not limited to, 21 CFR 210, 211, Part 11; knowledgeable about other regulatory guidance and expectations
· Experience across all quality operations functions, and technical expertise in manufacturing processes, controls and analytical testing used for aseptic finished drug products
· Possesses excellent communication skills (written and verbal); proven ability to present data to executive management in a clear, concise manner
· Experience with electronic Quality Management Systems (i.e. Veeva), ERP systems and Microsoft Applications (Outlook, Excel, PowerPoint, Word, etc.)
· Self-directed, results oriented, capable of handling multiple tasks and prioritizing work in a fast paced, dynamic work environment
· Demonstrates transparency in communication and effectively collaborates with external contractors and internal cross functional teams (i.e., Technical Operations, Regulatory Affairs, Supply Chain etc.) to assure quality and business objectives are met
· Possesses critical thinking skills, is comfortable using a risk-based approach, has strong problem-solving skills to determine root cause and CAPAs to prevent the potential for recurrence
CorMedix is an equal opportunity employer. The Company is committed to providing a safe, respectful, and professional work environment that is free from all forms of unlawful discrimination, harassment (including sexual harassment), and retaliation, and complies with all applicable laws prohibiting such conduct. CorMedix does not discriminate against any individual on the basis of race, religion, color, national origin, ancestry, sex, marital/civil union/domestic partner status, family or parental status, sexual orientation, age, disability, or any other status protected under applicable federal, state, or local law