We are seeking talented and passionate individuals who thrive in a fast-paced, team-oriented, and dynamic environment.
Please send cover letter and resume to email@example.com.
Current Job Opportunities
Director of Quality Assurance (Job Code DQA-01)
To apply, please send your cover letter and CV to Todd Jamison firstname.lastname@example.org.
Specify Job Code DQA-01 in the subject.
Kala Pharmaceuticals, Inc. is looking for an individual that will head up Kala’s QA function and oversee GXP (cGMP, GLP, GCP) activities for early stage development through commercial product. He/she will be responsible for overseeing audits/inspections, maintaining the company’s quality program, ensuring compliance with FDA and other worldwide health authority regulations/guidelines, maintaining site SOPs and other documentation.
- Manages all QA functions related to GXP activities (e.g., cGMP manufacture of clinical supplies and commercial product; GLP studies; GCP activities related to clinical trials)
- Builds on existing infrastructure to maintain a complete quality system at Kala
- Conducts vendor qualifications per Kala SOP
- Works with the R&D team to set and justify specifications
- Plans and oversees GMP audits of manufacturing activities to assess compliance with all pertinent regulations as well as with company SOPs. Works closely with R&D to identify, evaluate, and recommend solutions to issues identified in the performance of cGMP audits
- Plans and oversees GLP audits of nonclinical CROs to assess compliance with all pertinent regulations as well as with company SOPs. Works closely with R&D to identify, evaluate, and recommend solutions to issues identified in the performance of GLP audits
- Plans and oversees GCP audits of clinical sites and clinical CROs, to assess compliance with all pertinent regulations as well as with company SOPs. Works closely with Clinical group to identify, evaluate, and recommend solutions to issues identified in the performance of GCP audits
- Performs batch disposition activities for products manufactured by third parties.
- Manages product complaints for clinical supplies and commercial product, and ensures that appropriate investigations are conducted
- Reviews investigations and provides input into CAPAs. Tracks investigations to ensure closure
- Tracks change control documents received from third parties that require review and approval
- Sets up change control process at Kala
- Prepares clear and concise written reports of audit observations, including an assessment of compliance. Assesses adequacy of action plan. Conducts follow up activities as needed to monitor corrective actions. Provides recommendations for corrective action and tracks corrective action commitments until closure
- Responsible for employee training for GXP activities
Other Skills and Abilities
- Excellent verbal and written communication skills
- Excellent organization skills with great attention to detail
- Ability to interact effectively with all personnel within the organization, and externally with CMO, CRO personnel as well as investigators and study site personnel
- Bachelor’s degree in a scientific or health-related field required
- Master’s degree in a scientific or health-related field a plus
- Minimum of seven years of Quality experience in the biotechnology or pharmaceutical industries required
- Minimum of five years of Quality auditing experience in cGMP, GLP and GCP
- Advanced understanding of the application of cGMPs to early development and commercial products, FDA regulations and ICH guidelines required