Associate Director/ Director, Quality Assurance

Description:

We are seeking an experienced Associate Director/ Director, Quality Assurance (Aseptics) to join Mariana’s Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals.

Illustrative Breadth of Responsibilities:

• 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.

Requirements/Skills:

• Graduate degree in Chemistry, Pharmacy, Microbiology or another related science preferred but not required.
• 8+ years’ experience in the pharmaceutical industry, preferably in a nuclear medicine radiopharmaceutical environment, FDA-regulated environment and in QA Operations & Compliance of a strategic site or a global role; Pharma production experience indispensable and preferably deep knowledge in aseptic processing
• Quality Assurance / cGMP regulations in USA and Europe (self-inspections, auditing of third parties, complaint/deviation handling, GMP training, SOP-systems)
• Thorough knowledge of GCP, GMP and PV requirements
• Strong understanding of regulatory Quality Systems requirements
• Strong understanding of risk assessment and risk management fundamentals/tools
• Project Management: managing of cross-functional projects
• Strong affinity with and awareness of quality issues
• Open and clear collaboration and communication
• Shows the appropriate sense of urgency around given tasks
• Team building and process harmonization skills
• Excellent verbal and written communication skills
• Excellent problem solving and decision-making skills

Mariana Oncology’s Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions

EEO Statement

Mariana Oncology is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.