Senior Manager, Drug CMO, Quality Assurance

4 weeks ago

San Diego, California, United States Inovio Pharmaceuticals Full time

About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit
Job summary
The Senior Manager, Drug CMO, Quality Assurance is responsible for managing the quality oversight of multiple US and foreign contract manufacturing organizations (CMO) for the manufacture of Cell Banks, Drug Substances, Drug Products, and all outsourcing to support release testing, stability testing, and packaging and labeling. Since INOVIO is the sponsor of its products, the Quality department has the ultimate responsibility for the quality and compliance of products and their manufacture at these locations. The Senior Manager will perform quality review of batch records, including in-process data, release data, OOS, Change Controls, Deviations, and Investigations associated with product lot release to ensure products were manufactured according to cGMP. The Senior Manager will also review validation protocol/reports, stability protocols/reports, regulatory submissions, and perform data trending of multiple products.
Essential job functions and duties

  • Oversee quality management of both hard copy and electronic GMP databases of Drug CMO documentation (Quality Agreements, Supplier Qualification, Audits, Batch Records, Memos, etc.) for CMOs, laboratories, packaging and labeling, and distribution suppliers.
  • Generate reports; draft letters, memos, and correspondence as required for the management of CMOs, laboratories, packaging and labeling, and distribution suppliers.
  • Manage GMP Lot Release activities; maintaining and record keeping of generated GMP documents, review records for accuracy, compliance with relevant regulatory requirements and completeness, verify for presence of listed documents, issue and approve Compliance Statements, Certificate of Analysis, and TSE/BSE Statements.
  • Manage Stability Programs; author and review final product specifications, and product shelf life memos.
  • Manage packaging and labeling approval activities, including serialization and distribution as needed.
  • Create presentations of CMO data and drug quality metrics for board meetings, investors, partners, and collaborators.
  • Collaborate with CMC team to ensure alignment and timelines are met.
  • Review CMC sections for regulatory submissions.
  • Routinely travel to US and foreign facilities for face to face meetings, GMP audits, and person in plant at CMOs, laboratories, packaging and labeling, and distribution suppliers.
  • Manage GMP quality audits and supplier qualification of these facilities, and train other QA personnel in Drug Manufacturing audits.

Minimum requirements

  • Bachelor's Degree preferred.
  • Minimum 7 years of experience in a QA or QC role supporting plasmid manufacturing and/or testing
  • Prior experience in a CMO or in managing a CMO
  • Experience in Microsoft Excel and Powerpoint
  • Effective oral and written communication skills.
  • Excellent interpersonal and organizational abilities.
  • Keen eye for details and compliance issues in GMP records.
  • Maintain a high level of confidentiality.
  • Anticipate, identify, and resolve problems in a timely manner.
  • Research, analyze, summarize, and report information in an effective manner.
  • Demonstrate professional demeanor.
  • Work independently on a broad variety of projects.
  • Exercise discretion and independent and sound judgment.
  • Adaptability to changing needs and situations.

INOVIO offers a variety of competitive compensation & benefits to regular full time INOVIO employees including:

  • 401(K) retirement plan with Corporate Matching
  • Annual Incentives
  • Medical, Dental, and Vision
  • Generous Paid-time off program and company holidays
  • Hybrid work environment (Depending on the nature of your employment with INOVIO)
  • Physical, Mental, & Financial Wellness Program
  • Company-paid Life Insurance plans
  • Long & Short-Term Disability
  • Flexible Spending accounts for medical and dependent care expenses
  • Employee Discount Perks and so much more...

The annualized base salary range for this role is $160,000 to $190,000 and is bonus eligible. Individual pay decisions ultimately depend on various factors including, but not limited to, relevant experience, knowledge, skills, education, geography, internal equity and alignment with external market data.

Disclaimer

INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.

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