Senior Manager of Quality Control

  • Waltham, MA, USA
  • Full-time

Company Description

Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYSTM(KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which we have submitted a NDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease, which is currently in Phase 3 clinical development.

 

Job Description

Kala is an emerging pharmaceutical company on the verge of commercialization. We are seeking a Senior Manager of Quality Control.  This is an opportunity for the right individual to join Kala at a time where significant growth is occurring and the development of a scalable quality assurance system is key. He or she will help develop processes and procedures that reflect best practice and provide assurance that the products Kala releases to the market meet Kala’s quality standards and FDA regulations. The Senior Manager will work closely with the Manufacturing and Supply Chain department to assure that our products are available to meet customer needs. Come join an experienced and highly motivated team.

Job Responsibilities:

  • Support QC functions related to GXP activities (e.g., cGMP manufacture of clinical supplies and commercial product)

  • Manage contract laboratories that perform testing of clinical and commercial lots

  • Review and approve certificates of analysis received from contract laboratories

  • Review and approve deviations related to QC activities 

  • Review OOS and OOT Investigations

  • Perform audits of contract laboratories

  • Review raw materials and in-process and finished product specifications (purchasing, release and stability)

  • Perform trend analysis of testing data to establish purchasing and release specifications for in-process and finished product

  • Assist with preparation and review of NDA and SNDA submissions

  • Assist the preparation, review and approval of APR’s

  • Assist with selection and installation of an EQMS for Quality Operations

  • Create edit, review and approve SOPs

Qualifications

Our ideal candidate will have:

  • Minimum ten years of experience in the pharmaceutical industry and quality systems

  • A minimum of five years of QC laboratory experience

  • Bachelor’s degree in life sciences, preferably chemistry

  • Experience in regulatory inspections

  • Strong written and verbal communication skills

  • The flexibility to travel from 10% of their time to Kala’s contract laboratories

  • Experience performing oversight and audits of laboratories

  • A minimum of three years of experience working in companies that have an outsourced/ virtual business model

  • Experience reviewing and approving raw data, test results and Certificates of Analysis for raw materials, drug product intermediates and final product.

  • Experience reviewing and approving method transfer and method validation protocols and reports

Additional Information

All your information will be kept confidential according to EEO guidelines.