- Collaborate with cross-functional teams to develop and execute a robust validation strategy for equipment, utilities, and computer software assurance (CSA), that align with regulatory requirements.
- Work with various departments to define the validation scope, deliverables, and timelines.
- Review and approve validation documents including SOPs, protocols, specifications, test scripts, acceptance criteria, and reports.
- Ensure implementation, operation, and validation of GXP computerized systems follow GAMP 5 guidelines.
- Participate in risk assessments related to GXP equipment, utilities, and computerized systems.
- Identify and address potential risks to data integrity, security, and safety.
- Provide quality support for change control processes and activities that occur for any modifications to existing or new systems, equipment, instruments, or utilities to ensure validation requirements are assessed and fulfilled.
- Review validation exception records and investigations.
- Lead and participate in CSV vendor audits.
- Support biennial reviews of validated systems as required.
- Provide various quality support in other areas of Quality that include batch record review, data review, material release, vendor and regulatory audits, SOP review, and other document reviews, as needed.
- Minimum - Bachelor's or Masters's degree preferably in an Engineering, Science, Technical, or related fields.
- Relevant certifications such as CQA are preferred.
- 10+ years of experience in Quality Assurance and Validation within the biotechnology workforce.
- Thorough knowledge of applicable regulations and standards related to validation activities.
- Experience working in a cGMP environment.
- Detailed knowledge of GAMP 5 applications and CSA approach.
- Proficiency in Microsoft Suite
- Ability to manage daily work activities of this role with minimal supervision.
- Strong orientation for quality and cGMPs
- Strong collaborative skills.
- Highly self-motivated and detail oriented.
- Demonstrated level of respect for individuals
- High level of integrity and personal responsibility
- Work is normally performed: at a desk
- Lifting requirements: Under 20 lbs
- Travel requirements: Occasional
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Associate Director, Quality Assurance Validation - Morrisville, United States - Kriya Therapeutics
8 hours ago
Description
Who You Are
The Associate Director, Quality Assurance Validation plays a critical role in ensuring the integrity, compliance, and reliability of equipment, methods, processes, and computerized systems within the GMP environment.
This position provides support and quality assurance guidance to the Technical Operation's department ensuring that the lifecycle of the validation program follows all regulatory requirements.
In this role, you will use your knowledge to ensure site validation activities align with Kriya's Validation Policy, Site Validation Master Plan, and applicable Quality Systems.
How You ContributeEducation & Experience
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
Medical, Dental and Vision with 100% employee premium coverage ∙ Retirement matching ∙ Short and long-term disability benefits ∙ 12 company paid holidays ∙ Generous Time Off ∙ Cyber Safety protection ∙ EAP ∙ Company paid life insurance ∙ Equity ∙ and more
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently.
