Quality Assurance Training Coordinator
About the job
- A bachelor's degree, preferably in life sciences or a technical field, or an equivalent combination of education and relevant experience.
- At least 2 years of professional experience in a training or developmental capacity.
- Experience within the biopharmaceutical industry and a demonstrated understanding of cGXP's.
- Ability to synthesize information and demonstrate strategic thinking while staying organized and detail oriented.
- Ability to follow through in an ambiguous, fast-changing environment, meet deadlines under pressure, and prioritize and manage multiple projects simultaneously.
- Ability to work effectively with different personalities at all levels of the organization.
- Interpersonal, collaborative, stakeholder management, written, and verbal communication skills.
- Administer and maintain the GMP program and Learning Management System.
- Maintain current knowledge of applicable regulatory guidelines and regulations, and develop training programs to prepare employees 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, and assist with group training.
- Coordinate or provide annual GMP and GDP training.
- Administer training program schedules for standard operating procedures, GMP concepts, and organizational policies as required.
- Manage the employee training program and maintain metrics and reports; periodically review training files.
- Assign and track required training based on employee roles, curricula, job functions, and departmental requirements; monitor completion and overdue training and communicate or escalate as appropriate.
- Inform management of regulatory and cGMP deviations, assist in determining appropriate solutions, and verify 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 documentation is complete, accurate, attributable, and readily retrievable.
- Participate in learning and training to maintain competency in the role's 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 they remain appropriate.
- Support inspection readiness by retrieving training records, responding to training-related documentation requests, and acting as the training subject matter expert during inspections.
- Perform other duties as assigned.
- Experience with an electronic training system such as Veeva Training Vault.
About the company
Krystal Biotech develops and sells gene therapies for rare dermatological diseases. Its lead product, VYJUVEK (beremagene geperpavec-svdt), is a topical gene therapy designed to treat dystrophic epidermolysis bullosa (DEB) by delivering a corrected gene directly to the skin so that damaged skin can heal. The company’s STAR-D platform enables off-the-shelf gene therapies that can be used across a range of skin conditions and the VYJUVEK therapy is designed to be redoable, meaning its treatment can be repeated if needed. Krystal Biotech stands out by owning exclusive worldwide rights to its therapies and by being the first FDA-approved medicine for DEB, a rare condition. The company’s goal is to grow its portfolio of dermatology gene therapies using the STAR-D platform to provide accessible, repeatable treatments for patients with rare skin diseases.
Company Size
201-500
Company Stage
IPO
Headquarters
Pittsburgh, Pennsylvania
Founded
2016
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Simplify's Take
What believers are saying
- Q2 2026 VYJUVEK revenue hit $119.2M, up 24%, with 95% gross margin.
- UK approval in May 2026 and Spain-Italy launches target late 2026 expansion.
- KB803 readout is slated for 4Q 2026 after full enrollment in April.
What critics are saying
- Germany pricing negotiations run through 2H 2026, and France extends into 2027.
- Forman filed patent inventorship suit on May 29, 2026 over KB407-related CFTR patents.
- VYJUVEK concentration creates existential risk if DEB pricing access stalls or new ocular programs fail.
What makes Krystal Biotech unique
- VYJUVEK is first redosable gene therapy and first DEB medicine approved by FDA, EMA, MHRA.
- STAR-D delivers off-the-shelf topical skin gene therapy, avoiding patient-specific manufacturing.
- Krystal uses flexible home-or-clinic dosing, strengthening adherence in chronic wound care.
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Growth & Insights and Company News
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↑ 1%Krystal Biotech reported second-quarter 2026 revenue of $119.2 million from global sales of VYJUVEK, up 24% year over year. US sales reached $91.6 million, whilst net income rose to $54.8 million, or $1.79 per diluted share, from $38.3 million a year earlier. The company ended the quarter with over $1.1 billion in cash and investments. It has secured more than 730 US reimbursement approvals and is expanding outreach to community settings to reach potentially undiagnosed patients. European and Japanese revenue growth was constrained by a German pricing reserve, with negotiations expected to conclude in the third quarter. The company maintained its full-year 2026 expense outlook of $175 million to $195 million. Multiple pipeline milestones are approaching, including results from the IOLITE study of KB803 expected later this year.
Krystal Biotech reported second-quarter 2026 earnings that beat expectations but missed on revenue, sending shares down 7.65% in pre-market trading. The company posted adjusted earnings of $1.79 per share, exceeding the $1.70 consensus estimate. Product revenue reached $119.2 million, below the $122.3 million forecast, though up 24% from $96 million a year earlier. Net income rose to $54.8 million from $38.3 million in the prior-year quarter. The company reported a 95% gross margin for VYJUVEK, its flagship product, which secured over 730 reimbursement approvals and is prescribed by more than 640 healthcare providers. Krystal ended the quarter with approximately $1.1 billion in cash and investments. Commercial launches in Italy and Spain are expected before year-end.
Krystal Biotech reported $119.2 million in global VYJUVEK revenue for the second quarter of 2026, a 24% increase year-over-year. The gene therapy for dystrophic epidermolysis bullosa has generated $965.9 million since launch, with a gross margin of 95%. The company has secured over 730 reimbursement approvals in the United States and expanded to more than 640 prescribers. VYJUVEK continues gaining traction in Germany, France, and Japan, with launches planned in Spain and Italy later this year. The UK approved VYJUVEK in May, and pricing discussions are underway. Additional marketing applications are expected in Switzerland and Australia during the second half of 2026. Krystal ended the quarter with $1.1 billion in cash and investments. The company is advancing multiple clinical programmes across eye, lung, and skin conditions.
Krystal Biotech's share price rose 7.9% following its promotion from the S&P 600 to the S&P 400 index earlier this month. The biotechnology company also joined the S&P 400 Health Care and Biotechnology indices. Additionally, Krystal filed a response with the US Patent and Trademark Office containing single-patient data from its investigational KB801 gene therapy for neurotrophic keratitis. The company noted the data showed complete closure of a persistent corneal epithelial defect in one patient from a discontinued study. Krystal emphasised the early-stage nature of the data and said it should not be used to draw efficacy conclusions. The index inclusion increases the company's exposure to mid-cap index funds. Analysts expect Krystal's investment case remains focused on its VYJUVEK rare disease franchise and upcoming pivotal data across its gene therapy pipeline.
Brown Capital Management's Small Company Fund added Krystal Biotech, Inc. (NASDAQ:KRYS) to its portfolio in the first quarter of 2026, according to its investor letter. The commercial-stage gene therapy company develops treatments for rare skin disorders using topical, re-dosable gene therapy. Krystal's lead product, VYJUVEK, is the first FDA-approved topical gene therapy for dystrophic epidermolysis bullosa. The treatment has exceeded commercialisation expectations with rapid patient adoption and strong payer acceptance, generating gross margins near 94%. The company reported $389 million in revenue for 2025 with a 42% operating margin. Brown Capital expects approximately 30% annual revenue growth and operating margins rising to 50% in coming years. The fund cited Krystal's recession-resistant revenue stream and expansion into European and Japanese markets as key investment drivers.