29 Jan

Senior Manager Quality Systems And Administration Jobs Vacancy in Kala Pharmaceuticals Waltham

Position
Senior Manager Quality Systems And Administration
Company
Kala Pharmaceuticals
Location
Waltham Maluku
Opening
29 Jan, 2018 23 days ago

Kala Pharmaceuticals Waltham urgently required following position for Senior Manager Quality Systems And Administration. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Senior Manager Quality Systems And Administration Jobs Vacancy in Kala Pharmaceuticals Waltham Jobs Details:

Kala is an emerging pharmaceutical company on the verge of commercialization. We are seeking a Senior Manager of Quality Systems and Administration to establish our Quality System’s foundation and strategy moving forward. This is an opportunity for the right individual to join Kala at a time where he or she will be able to build our Quality Systems to prepare Kala for our significant future growth. Our ideal candidate will have the opportunity to participate in the selection, validation and implementation of our Quality Management System. Come join an experienced and highly motivated team.

Key Responsibilities for this role will include:

  • Lead the project of the selection, validation and implementation of our QMS
  • Provide the ongoing management and administration of the Quality Management System (QMS) processes.
  • Ongoing system owner of both our Controlled Document Management System and Training System
  • System administrator and Super-User for the following quality processes: Change Control, Quality Issues, CAPA, Audits and Complaints.
  • Coordinate user training for the Quality Management System (QMS) processes.
  • Coordinate the preparation of Annual Product Reviews and Annual Reports

Our ideal candidate will have:

  • Bachelor’s degree in systems, life sciences or related fields
  • Ten plus years of direct experience in managing electronic document management and training systems.
  • Experience managing and using paper-based and electronic quality management systems (EQMS) for change control, quality Issues, CAPA, audits and complaints.
  • Effective at partnering with leaders and subject matter experts to design systems that meet business needs and ensure ongoing regulatory compliance
  • Experience in regulatory inspections.
  • Experience authoring and reviewing batch records, standard operating procedures (SOP), training materials, specifications, annual product reviews and FDA submissions.
  • Experience delivering classroom and structured OJT training programs, including user training for document management, training management and other quality processes.
  • Strong written and verbal communication skills.
  • Proven track record demonstrating strong leadership skills.
  • Detail oriented; able to coordinate tasks that cross multiple systems and areas.

About Us: 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 Type: Full-time


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