Clinical Quality Assurance Manager

If you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of infections, then Melinta Therapeutics might be the right place for you. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.

Melinta provides innovative therapies for acute and life-threatening illnesses, with commercial and medical capabilities, specializing in infectious diseases and acute care. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. Melinta’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. Visit www.melinta.com for more information.

Job Overview

The Clinical Quality Assurance Manager is responsible for implementing, maintaining, and ensuring the effectiveness of the Good Clinical Practices (GCP) Quality processes to ensure high quality pharmaceutical products comply with global regulatory requirements. The Clinical Quality Assurance Manager will serve as a strategic partner to the Vice President, Technical Operations and Quality and will be focused on developing Melinta’s GCP quality strategies and Clinical QA Global function.

Duties and responsibilities

• Represent Quality Assurance (QA) on the clinical and nonclinical teams and provide compliance advice and guidance as needed
• Responsible for establishing the Clinical Quality Function program
• Author and implement the applicable Procedures (SOPs), policies, and work Instructions to ensure that Clinical QA practices are aligned with applicable regulations and requirements
• Identify Clinical Ops and Clinical QA training needs within Melinta and ensure training requirements are met
• Keep track of Applicable studies to ensure subject safety, protocol adherence, and accuracy of reported data
• Develop and implement Melinta’s Global Clinical QA strategy, goals, and objectives. Assure that the strategy is being implemented, that Melinta continues to produce high quality developmental products and remains in compliance with worldwide GCP regulations
• Partners with Clinical Operations and other key stakeholders in the qualification process of new vendors or new services to be utilized from existing vendors and assess associated risk and potential audit requirements
• Implement the Clinical QA Audits and Inspection Program
  • Perform and/or manage the vendors, investigator sites, testing sites and CROs Audits and follow up findings until closure
  • Develop and Maintain the Audit Master Schedule for each protocol
  • Perform and/or manage the Internal Audit of the Clinical Organization. Audit Melinta’s GCP activities to ensure that sound quality principles are in place throughout the organization, and that regulated activities comply with global expectations
  • Develop and maintain a Clinical Approved vendor list
  • Serve as Melinta QA representative for Clinical regulatory audits of Melinta and its vendors by regulatory agencies and partners including provision of on-time responses as required to ensure that satisfactory outcomes are achieved
  • Serve as primary contact with regulatory agencies for response to Clinical related inspection reports
• Monitor Vendors and CROs compliance of Melinta with global and GCP requirements related to GCP activities
• Lead investigation of serious noncompliance of clinical investigators as needed. Participate in decisions with Clinical and Regulatory Affairs to discontinue clinical investigators for noncompliance.
• Manage and Communicate Clinical related Quality issues and observations. Suggest and implement remedial actions. Report promptly all significant deviations from Good Clinical Practices to Melinta senior management
• Monitor trends to address and resolve Clinical Quality compliance issues
• Optimize the effectiveness of the Melinta drug development process through use of sound quality principles and measurement of key indicators such as inspection outcomes, protocol deviations, clinical investigators site audits, IRB/EC audits and vendor audits
• Assist and provide feedback to the Clinical Operations functional area when vendors (such as CRO, Data Management Services, etc.) by providing oversight of plans, logs, and trial management documentation development. Approve Clinical studies product labels and Batch records
• Maintain accountabilities for relevant timelines and deliverables
• Build mutually respectful and collaborative working relationships with Clinical operations, Regulatory Affairs, Quality Assurance, and other key functions within Melinta

Qualifications

• Registered Nurse (RN) or RN equivalent, or bachelor’s degree in a scientific related field
• An equivalent combination of education and experience may be considered
• At least 10 years of experience managing Clinical Quality Programs involving drug development in the pharmaceutical/biological industry
• Thorough knowledge of the drug development process and Quality/Regulatory interactions, including FDA and ICH standards and recommendations
• Well versed in current international GxP regulatory requirements, possess strong leadership skills, as well as communication and negotiation skills
• Broad exposure and understanding of clinical research activities, including investigator responsibilities
• Extensive knowledge of the pharmaceutical development process including preclinical and clinical studies as well as manufacturing and the Quality/Regulatory requirements impacting this process
• Leadership competencies, including relationship building, influencing, fostering teamwork, knowledge of the business, sound judgment, and the ability to make difficult decisions. Experience managing partner relationships

Position Type

Full Time (In Office minimum 3 days a week / Hybrid Schedule)

Travel

• Preference for position to be in Lincolnshire IL office location
• Will consider flexible work options
• As needed, approximately 5%

Melinta Therapeutics appreciates your interest in our company as a place of employment. It is our Company's policy to employ, retain, promote, terminate and otherwise treat all employees and job applicants without regard to any individuals’ age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.