Description

Job Purpose

The Quality Assurance Manager is responsible for overseeing and directing quality assurance activities for Ocugens novel gene therapies for the treatment of ocular diseases as well as supporting Ocugens COVID-19 vaccine manufacturing, COVAXIN. This includes, oversight of external partners and management of ongoing manufacturing and lot release and supporting IND and BLA submissions.

Duties and responsibilities

• Support external manufacturing by providing QA oversight in collaboration with external QA partners
• Building impactful relationships and collaborations across the organization to achieve corporate goals
• Perform the Quality Assurance role for OCU400/410 and Covaxin. Activities include, but are not necessarily limited to, review/approval of:
  • Review and approve critical compliance documents in support of GMP
  • Executed batch records for compliance
  • Certificate of Analyses against raw data and/or specifications for compliance
  • Review of deviations, non-conforming materials, out of trend/calibration and specification results and ensure appropriate investigation and product impact assessment are performed and closed
  • Review of stability report against protocol and raw data
  • Risk assessments associated with assigned projects
  • Release of Ocugen owned raw materials, packaging components and products as needed
  • Review of project specific procedures, protocols and reports as needed
  • Support Quality Assurance Audits
  • Support Ocugen Inspection Readiness Program
  • Provide QA support to IND and BLA submissions
• Work on continuous improvements, knowledge management, and striving for operational excellence
• Schedule and perform external audits
• Perform audits and/or site visits of suppliers and contracted facilities related to project acticities
• Quality review of regulatory filings in support of projects

Qualifications

• Bachelor's degree in a science discipline or related field is preferred
• Minimum of 10 years' experience in a quality assurance role of increasing responsibility, CQA a plus
• Higher level understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products
• Experience in Gene Therapies
• Experience in supporting Quality Control partnerships
• Experience in plant start up is highly desirable
• Advanced knowledge of manufacturing, clinical and analytical services in the pharma industry, gene therapeutic knowledge preferred
• Working knowledge of GLP and GMP international regulations and ICH guidelines
• Strong problem-solving skills
• Superior project management and communication skills
• Ability to work independently and effectively as a team member with multidisciplinary project
• Attention to detail with the ability to perform critical review of various types of documents.
• Strong organizational and time management skills

Working Conditions

This job operates in an office setting and may include 20-30% of travel for audits and/or site visits of project vendors.

Physical Requirements

This is a largely sedentary role.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individuals conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.