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Quality Assurance Manager

Malvern, PA | Full Time
10 Days Ago

Job Description

Job Purpose                                                                                                                                                                                                                                         

The Quality Assurance Manager is responsible for overseeing and directing quality assurance activities for Ocugen’s novel autologous cell-based therapy for the treatment of damaged knee cartilage (Neocart).  This includes establishment of Quality processes for our internal manufacturing capabilities, oversight of external partners and management of ongoing manufacturing and lot release.

 

 Duties and responsibilities

  • Work to establish Quality Assurance processes/documents/systems for internal manufacturing
  • Building impactful relationships and collaborations across the organization to achieve corporate goals
  • Perform the Quality Assurance role for Neocart. 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
  • Work on continuous improvements, knowledge management, and striving for operational excellence
  • 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 autologous Cell-based 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 individual’s 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.

Skills for Quality Assurance Manager

The job skills required for Quality Assurance Manager include Quality Assurance, Quality control, Continuous Improvement, Problem Solving, GMP,and Internal Audit etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Manager. Select any job title you are interested in and start to search job requirements.

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Career Path for Quality Assurance Manager

The following is the career advancement route for Quality Assurance Manager positions, which can be used as a reference in future career path planning. As a Quality Assurance Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Manager. You can explore the career advancement for a Quality Assurance Manager below and select your interested title to get hiring information.