Quality Systems Specialist Ii

Company Overview

Pyros is a specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare diseases with unmet needs. With an initial focus on Infantile Spasms (IS) - a rare and sometimes life-threatening form of pediatric epilepsy - we recognize the significant emotional burden this condition imposes on families. Pyros is working to offer an enhanced treatment option for families affected by IS and other rare diseases.

Role Summary

The Quality Systems Specialist II, reporting to the Senior Manager, Quality & Compliance, will be associated with managing Pyros’ Quality Management System. This individual will have experience working in a regulated pharmaceutical/biotech environment and will be expected to interact with personnel across all levels and functional areas within the company as well as external partners. This position will encompass various tasks, including but not limited to, adequately controlling documentation and other Quality records, aiding, and overseeing Quality Assurance processes, developing, and maintaining department KPI (Key Performance Indicator) metrics, and additional responsibilities as assigned.

Responsibilities

• Implementation, maintenance, and continuous improvement of the following Quality Systems:
  • Change Controls – Provide input and assist change owners by providing independent QA assessment. Responsible for initiation of changes within QA for specific processes in relation to this job description.
  • Investigation/CAPA/Complaints - Provide support for the review and approval of investigations. Support and determine appropriate corrective/preventative actions as a result of investigation findings. Responsible for investigating and documenting complaints.
  • Document Control - Develop, facilitate, and execute procedures including the creation, routing, review, approval, training, distribution, periodic review, and archiving of new and revised controlled documents from both internal and external sources.
  • Veeva and DocuSign - Handles and ensures quality of documentation (control, retention, and archival) to support cGMP activities.
• Serve as the internal and external QA liaison for all Quality System requests.
• Assists as needed with maintaining the supplier qualification process.
• Conducts Change Control Review Board meetings for supplier notifications.
• Document Control - Develop, facilitate, and execute procedures including the creation, routing, review, approval, training, distribution, periodic review, and archiving of new and revised controlled documents from both internal and external sources.
• Investigation/CAPA/Complaints - Provide support for the review and approval of investigations. Support and determine appropriate corrective/preventative actions as a result of investigation findings. Responsible for investigating and documenting complaints.
• Assist in creation of and compiling KPI/metrics and performing trending analysis of the QA systems to ensure compliance and drive continuous improvement activities.
• Create and maintain indices and databases related to all Quality Assurance functions (i.e., Change Controls, Internal/External Investigations/CAPAs, Internal and External Audits, etc.).
• Veeva and DocuSign - Handles and ensures quality of documentation (control, retention, and archival) to support cGMP activities.
• Escalates potential risks to management during planning, review, data validation, data review, and archival processes.
• Change Controls – Provide input and assist change owners by providing independent QA assessment. Responsible for initiation of changes within QA for specific processes in relation to this job description.

Skills & Requirements

• Experience with cGMP documentation is required.
• Technical experience of working at a manufacturing facility with the ability to understand and interpret regulatory requirements is required.
• Demonstrates the ability to lead multi-functional teams.
• In-depth knowledge of Regulatory/Compendial requirements, pharmaceutical quality, and Quality Systems, with broad experience and exposure to best practices is required.

Qualifications

• Excellent oral/written communication, problem-solving/issue resolution, and prioritization skills required.
• Ability to work independently and in a team environment.
• Proficiency in Microsoft Word, including editing, formatting, creating/utilizing templates, creating forms, embedding hyperlinks, and basic experience and competency with Excel and DocuSign is required.
• BA/BS degree in a related field or equivalent experience with a minimum of 3 years related work history, in a similar or advanced position within a regulated environment required; preferably reporting into a QA function.
• Understanding of Quality requirements and Pharmaceutical Regulations including, but not limited to 21CFR211, 21CFR11, Good Documentation Practices, and ALCOA+.

• Understanding and knowledge of the use of electronic systems in a highly regulated industry.

Physical Demands

• Occasionally mobile within home office environment.
• Routinely in a stationary position for extended periods of time.
• Constantly operating a computer, printer, telephone, and other similar office machinery.

Benefits

• 401(k) with company match
• Generous holidays
• Medical, dental, vision (most tiers are fully compensated by Pyros)
• Generous PTO with rollover
• Competitive salary and benefits package
• HSA and FSA
• Life and supplemental life insurance

Pyros is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

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