About this role
Build Your Career at Krystal BiotechThanks for visiting our Career Page. Explore our current opportunities and apply to positions that match your experience, interests, and qualifications.About Krystal BiotechHeadquartered in Pittsburgh, Pennsylvania, Krystal Biotech has rapidly emerged as a global leader in gene therapy since 2016. The global approvals of the first-ever redosable gene therapy reflect our commitment to transforming groundbreaking science into life-changing treatments for patients with high unmet medical needs.Our approach brings together innovative science and technology, rapid and reliable manufacturing, and a patient-focused commercialization model as we continue to advance a robust pipeline of investigational genetic medicines.At Krystal, breakthrough innovation starts with exceptional people.
We foster a collaborative, inclusive, and fast-paced environment where curiosity is encouraged, diverse perspectives are valued, and every employee can make an impact.Whether you're in the lab, on the manufacturing floor, in the field, or supporting our business operations, you'll be part of a company led by its founders, where every role supports our mission to bring transformative therapies to patients around the world.Benefits That Support YouWe offer competitive compensation and a comprehensive benefits package designed to support our employees both at work and outside of it.Equity CompensationMedical and Prescription Drug CoverageDental and Vision InsuranceShort and Long-Term Disability Insurance401(k) With Company Match401(k) Annual Student Loan Match ProgramPaid HolidaysPaid Time OffFlexible Spending Accounts (Health Care & Dependent Care)Health Savings AccountEmployee Assistance Program & Benefits Concierge AppAD&D and Life InsuranceWellness Rewards ProgramQuality Assurance Training CoordinatorPittsburgh, PAFull TimeQuality AssuranceMid LevelShareAbout Krystal Bio:At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan.
We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.Position Summary:Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Assurance Training Coordinator. The Training Coordinator will be responsible for administering, maintaining and executing training systems while supporting the Quality function.
This position will focus on ensuring cross-functional compliance with all company policies, procedures, cGMP’s and other regulatory requirements.Responsibilities will include, but are not limited to, the following:Administer and maintain the GMP program and Learning Management System; experience with Veeva is preferred but not required.Maintain up-to-date knowledge on all applicable regulatory guidelines and regulations, and develop training programs to ensure employees are equipped to succeed on cGMPs and other regulations.Participate in compliance evaluation of regulated activities within pharmaceutical development and cGMP manufacturing.Develop and update GMP training materials for new-hires, existing employees, contractors and visitors; assist with group training.Coordinate and/or provide annual GMP and GDP training.Administer training program schedules on standard operating procedures (SOPs), GMP concepts and organizational policies, when required.Manage employee training program and maintain metrics/reports; review all training files periodically.Assign and track required training based on employee roles, curricula, job functions, and departmental requirements. Monitor training completion and overdue training and communicate/escalate as appropriate.Inform management of deviations from regulations and cGMP and assist in determining appropriate solutions while verifying that assigned actions have been implemented.Collaborate with Quality Assurance, Manufacturing, Quality Control, Facilities, Supply Chain and other functions.Maintain employee training records and ensure training documentation is complete, accurate, attributable, and readily retrievable.Participate in learning and training to be competent in above functions.Generate and review training metrics, including overdue training and on-time completion.Support investigations and CAPAs related to training deficiencies or training-system issues.Assist with periodic review of training curricula and employee training assignments to ensure continued appropriateness.Support inspection readiness by retrieving training records and responding to training-related documentation requests, as well as acting as SME for training during inspections.Other duties as assignedRequirements and Preferred Qualifications:Bachelor’s degree, preferably in life sciences or technical field, or equivalent combination of education and relevant experience2+ years of professional experience in a training or developmental capacity. Experience in an electronic training system such as Veeva Training Vault preferred.Experience within biopharmaceutical industry is highly preferred along with a demonstrated understanding of cGXP’sHighly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinkingHighly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressureDemonstrated ability to prioritize and manage multiple projects simultaneouslyDemonstrated ability to work effectively with many different types of personalities at all levels of the organizationExcellent interpersonal, collaborative and stakeholder management skillsExcellent communication skills (written/verbal)Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.
Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers.Krystal Biotech, Inc.does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.#LI-CF1ShareApplyApply for this positionRequiredFirst NameLast NameEmail AddressPhoneAddressResumeWe've received your resume. Clickhereto update it.Attach resumeorPaste resumeAttach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) orPaste resumePaste your resume here orAttach resume fileCover LetterAre you willing to relocate?No answerYesNoWhat's your citizenship / employment eligibility?No answerI am a U.S.
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