Mariana Oncology

Compliance

• Provide leadership for all quality and regulatory aspects of Chemistry, Manufacturing and Controls (CMC)
• Assure optimal functioning of internal and external interfaces between CMC, Quality Assurance, Regulatory Affairs and stakeholders
• Proactively manage Regulatory aspects of CMC programs including understanding and ability to review internal and external source data for accuracy
• Responsible and accountable for secure vault data stream and quality of all data submitted
• Proactively manage Regulatory aspects with strong CMC focus
• Ensure timely delivery of high-quality CMC portion of documents
• Support and comply with procedures established by Quality and Regulatory Operations functions
• Facilitate the development of, reviews, and comments on all technically complex CMC documentation
• Articulate and resolve CMC issues to project teams and external stakeholders
• Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings
• Develop and maintain excellent relationships with regulatory authorities, corporate partners

Associate Director, CMC Regulatory

Director

• Lead the integration from Mariana’s legacy QMS to Novartis’ QMS platform
• Be the system owner and Subject Matter Expert for quality systems (EDMS, EQMS, LMS) at Mariana
• Review GMP documentation to support the Quality Systems including Document Management, Change Control, Deviations, CAPA, Supplier Management, Risk, and Audits
• Collaborate cross-functionally, including but not limited to liaising with QA, Regulatory Affairs, CMC, Preclinical Development, Manufacturing, etc.
• Liaise between IT and Operations for QMS process/system enhancements and process improvements
• Author, review, and, when appropriate, approve policies, procedures, and other related documents for the QMS processes
• Lead the implementation and/or evolution and execution of QMS GxP training program
• Manage GxP document archive
• Manage internal and external audit documentation, while acting as an SME for electronic QMS
• Establish and/or refine systems governance KPIs and create a culture of continuous improvement

Associate Director, Quality Systems

QA Engineer

• Provide specialist knowledge for sterile pharmaceutical processes and process technologies to the Mariana sites
• Accountable for implementing/complying with current standards on Sterility Assurance, including media fill, smoke studies, environmental monitoring, equipment and facility design
• Implement Aseptic improvement projects with the identification of weaknesses, creation of guidance, training, roll out and verification of correct implementation of processes, and standards to maintain and improve existing and to implement new innovative manufacturing technologies
• Act as a point of liaison between the Mariana sites and the Aseptics network within Novartis
• Support all GMP relevant tasks/issues (operational and strategic) by ensuring compliance with internal quality standards, relevant regulatory requirements, filed product quality standards and SOPs in place
• In collaboration with the site Quality team, contribute to the appropriate oversight, assessment and mitigation of risk to quality practices, processes and systems to ensure that all aspects are complying
• Support the site in implementing and aligning to fundamental guidelines in the area of sterile manufacturing and analysis
• In collaboration with Site SMEs, work to ensure alignment and best practices in regular training and education programs provided to Site Process Experts and Operators
• Develop guidance documents on aseptic topics in the production and micro lab environment
• Develop / review protocols, reports, risk assessments with the sites
• Support the site by providing expertise and by harmonizing and optimizing related technical processes
• Identify areas of potential weakness, develop and help the site implement a contamination control strategy
• Aseptic support for major sterility assurance issues e.g. sterility failures, major EM deviations, media fill failures
• Acts as the global SPOC to define and implement new technical standards for existing and new technologies and equipment and facilities
• Provide input on basic requirements for User Requirements (URS) ensuring that quality is embedded in the equipment design
• Support the validation and implementation of new products to the Mariana site
• Provide the necessary support in any internal or external audit and review regulatory documentation
• Monitor and support the site on current aseptic processing practices, and current trends and inspection reports on Sterility Assurance
• Shop floor optimization / aseptic training (one off activities linked to changes or new topics)
• General aseptic topics, CAPA identification/verification (regular activities)
• Major contamination issues (ad hoc)
• Regulatory audit support in particular FDA (regular activities)
• Validation support (initial support e.g. smoke studies)
• Collaborate with the Function Managers to guarantee the correctness of the Quality Management System
• Ensure continuous improvement of QA system and processes, systematic improvement of compliance and operational level active collaboration in quality related projects across teams
• Management of change controls, deviations, and CAPAS
• Support in Complaint handling

Associate Director, CMC Regulatory

Associate Director, Quality Systems

Associate Director, Quality Assurance