Sr Manager Software Developer Validation Quality Professional [28541]

$200,000 - $225,000/Yr

Stealth - Nutley, NJ

Full-time - Manager

Nutley, NJ

Oil and Gas Extraction

About the position

The Sr Manager Software Developer Validation Quality Professional at Stealth is a pivotal role that focuses on ensuring the quality and compliance of software systems within the pharmaceutical industry. This position serves as the Quality Assurance approver for internal computer system validation efforts, acting as a crucial liaison between the business and technical teams. The individual will provide guidance and consultancy on system validation processes, ensuring that all software development life cycle (SDLC) activities adhere to regulatory standards and internal quality benchmarks. In this role, the Sr Manager will support computer system audits, reviewing SDLC and data integrity controls to ensure compliance with industry regulations. They will also be responsible for reviewing Corrective and Preventive Actions (CAPA) and verifying the effectiveness of these actions following system audits. Additionally, the individual will play a key role in preparing for health authority audits and inspections, ensuring that the organization is inspection-ready at all times. This hybrid position requires a blend of technical expertise, regulatory knowledge, and strong communication skills to effectively manage multiple projects concurrently while maintaining high standards of quality and compliance.

Responsibilities

• Act as the Quality Assurance approver for internal computer system validation efforts.
• Serve as a liaison to the business for guidance and consultancy on system validation.
• Support computer system audits for review of SDLC and data integrity controls.
• Review CAPA and verify the effectiveness of CAPAs from system audits.
• Prepare for health authority audits and inspections to ensure inspection readiness.

Requirements

• Bachelor's degree in associated functional disciplines including IT, Data Sciences, or similar fields.
• Minimum 8 years' experience in the pharmaceutical industry or a similar field.
• Familiarity with software development methodologies, including Agile and Waterfall.
• Knowledge of coding matrix and complexity measurements/determination.
• Familiarity with regulations governing software development and validation.
• Strong professional communication skills and independent time management abilities.
• Ability to manage multiple projects concurrently.

Nice-to-haves

• Knowledge of Statistical Programming is preferred but not required.
• Knowledge of GCP/GMP is preferred.
• Auditing experience is preferred but not required.

Benefits

• Full Suite of Benefits
• Paid Time Off (PTO)
• Paid Holidays
• 401K
• Hybrid Work Role