Manager - QA CSV and Data Integrity

May 30

🌪️ Kansas – Remote

Although this job is listed in Kansas, this company may be open to hiring remote in other states.

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

Altasciences

WebsiteLinkedInAll Job Openings

Altasciences is a forward-thinking, mid-size early phase contract research organization located in Canada and the U. S. , catering to biopharmaceutical companies of all sizes. The company specializes in offering a flexible approach to early drug development, with services that include preclinical safety testing, clinical pharmacology from Phase I to Phase II, bioanalysis from preclinical to Phase IV, as well as research and manufacturing analytical services. Altasciences is committed to accelerating early-phase drug development, ensuring seamless transitions from lead candidate selection to proof of concept and beyond, thereby delivering impactful results with a personal touch.

Clinical Research • Clinical Trials • Phase I-II • Human Abuse Liability & Abuse Potential • Early Cardiac Safety & TQT

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

💰 Private Equity Round on 2017-06

📋 Description

• Supervises and is responsible for providing Quality Assurance (QA) oversight, collaboration and review of Computerized System (CSV) Lifecycle validation deliverables and leading corporate Data Integrity initiatives. • Acting as subject matter expert for QA in CSV and data integrity. • Provide Quality oversight, review and audit of CSV and equipment validation documentation. • Develop training programs and provide training for team members. • Represent all sites regarding QA CSV in meetings. • Lead and manage initiatives related to CSV and data integrity. • Support client audits, computer system vendor qualifications and audits, and regulatory inspections. • Provide QA support and input to enforce CSV and Data Governance guidelines, policies and procedures. • Optimize CSV auditing processes throughout all sites. • Assist with revision or creation of SOPs, policies as well as QA tools and templates, with related training, related to CSV and Data Integrity. • Responsible for overseeing the development of QA auditing guides and tools for validated systems. • Ensure that the Computerized System Validation Lifecycle efforts are in compliance with 21 CFR Part 11 and applicable FDA/EMA Guidance on electronic data integrity. • Participate in site, business unit, and corporate quality and process improvement initiatives related to CSV and Data Integrity as needed. • Communicate all identified compliance and quality risks to management. • Conduct data integrity risk assessments and consult in risk mitigation strategies as needed. • Responsible for staff development. • Ensures the regulatory trends in the industry are transposed, communicated and transferred to the QA staff.

🎯 Requirements

• Bachelor's degree (B.S.) or higher, specializing in a scientific or equivalent combination of education and experience. • 5+ years’ related experience as a quality assurance professional specific to computer system validation and regulatory compliance oversight in a regulated environment. • A minimum of 3 years in supervision of personnel is required. • Professional certification such as RQAP-GLP or GCP (Registered Quality Assurance Professional-GLP or GCP) or ASQ-CQA (American Society of Quality Certified Quality Auditor) or other certification is recommended. • Basic computer skills (Microsoft Office Suite) required.

🏖️ Benefits

• Health/Dental/Vision Insurance Plans • 401(k)/RRSP with Employer Match • Paid Vacation and Holidays • Paid Sick and Bereavement Leave • Employee Assistance & Telehealth Programs • Training & Development Programs • Employee Referral Bonus Program • Annual Performance Review