Senior Director Quality Assurance GMP & QA Operations

Location
Newark, CA
Posted
May 17, 2022
Ref
4354453004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Senior Director Quality Assurance GMP QMS & QA Operations

Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options.  Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.

The Senior Director, Quality Assurance GMP QMS & QA Operations will support and direct the quality operations and quality management systems and activities of RAIN in its product development and commercialization efforts. This person will work closely with the VP of Quality, the Senior Director of Quality, and the company's CMC group assuring accurate and timely flow of information and requirements including specifications, batch records, and product release for APIs and pharmaceutical drug products, in compliance with company standards and cGMP procedures. The primary focus of this job is to provide a reliable and timely supply of company products for clinical release and for clinical trials, requiring a close and cooperative relationship with contract manufacturers.

 

Key Requirements:

  • Develop and maintain essential quality systems in Box and EDMS systems for both clinical and commercial environments, including document control (including SOPs), exception management, change control, CAPA, training, validation, and auditing

    • Release manufactured APIs and drug products
    • Ensure that the appropriate review and approval of Master Batch Records, Executed Batch Records, SOPs, Change Control Documentation, Product Labeling and Revisions, Audit Reports, Validation Documentation, Product Specifications, Analytical Methods, and Contractor Qualifications are executed
    • Approve specifications for all APIs and drug products
    • Participate in the selection of suitable contract manufacturers and laboratories
    • Perform internal audits of RAIN operations, as well as audits of contract manufacturers, packagers, and labeling companies, contract laboratories, and GLP testing facilities
    • Perform required activities to maintain the GLP Quality Assurance Unit
    • Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution
    • Ensure compliance of internal operations and contract organizations with cGMP standards
    • Support and host and manage audits by regulatory agencies
    • Ensure the Company is kept current with all new quality-related regulatory requirements and provide guidance to senior management on the implications of any new or updated requirements
    • Hire, manage, support, develop/train QA staff and consultants and secure sufficient resources to support the company's goals and objectives.

Preferred Education and Experience:

  • Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards:
    • Strong proven hands-on experiences with GLP, GMP, GCP compliance matters, and contractor management in the pharma industry
    • Experience working with contract manufacturers
    • Experience with the regulatory submission and approval process
    • Previous experience with building QA systems and company-wide SOP systems for all phases of clinical Development
    • Understanding of scientific methods and the ability to interpret and communicate scientific data internally and externally
    • Independent and self-directed
    • Excellent communication and organization skills
    • Proficiency with eCTD software, quality management systems/document management systems, review management/version control software, BOX, Slack, Microsoft Office, and Adobe Acrobat,
    • knowledge of Veeva a plus
    • Ability to travel as required
  • BS/BA in Physical sciences or related field with an advanced degree desirable

    • Minimum of 12 years' progressive quality assurance experience in clinical or commercial pharmaceutical operations and development; experience in both development and commercial operations required

Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.