Senior Manager, Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for ensuring quality oversight in the manufacturing of biologics sterile drug products (DP) and combination products, which encompasses design control and Design History File (DHF) requirements.

• Tasked with executing strategies and approaches to uphold GxP compliance.

• Lead the quality elements and provide quality assistance during DP tech transfers.

• Serve as a liaison with CMO Quality partners to convey QA policies and procedures.

• Collaborate with contract manufacturers and internal stakeholders to resolve deviations/investigations and compliance concerns.

• Oversee material disposition for commercial and clinical DP/combination products.

• Examine executed batch records and related documentation for material disposition.

• Review and authorize GMP documentation including master batch records, deviations, change controls, specifications, and various protocols and reports to facilitate GMP production.

• Review and endorse validation protocols and reports, such as process validation, shipping validation, cleaning validation, etc.

• Provide support during both internal and regulatory agency audits as necessary.

• Perform Person-in-Plant duties as needed.

• Participate in the Material Review Board as required.

• Assist in defining and implementing suitable quality standards/specifications, methods, systems, and metrics for clinical and commercial quality operations.

• Act as the Quality representative on designated product teams to advocate for compliance and quality assurance.

• Lead the Quality Agreement with external partners.

• Support product lifecycle and ongoing process verification.

• Willingness to travel 10-20%, both domestically and internationally.

⛳️ Requirements

• Bachelor's degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related discipline; an advanced degree is preferred.

• At least 10 years of experience in a GMP Quality, Compliance, and/or Regulatory environment.

• Minimum of 6 years in a GMP QA role, preferably with direct experience in biologics sterile DP manufacturing/aseptic processing, including vials and prefilled syringes/autoinjectors.

• Exceptional written and verbal communication skills, demonstrating the ability to effectively engage in a project team setting, within departments, across functional groups, and with external collaborators.

• Strong innovative capabilities in problem-solving and peer influence.

• Comprehensive knowledge of FDA, ISO, EMA, GMP, and ICH quality systems and regulatory standards.

• Experience collaborating with external partners.

• A strong attention to detail is essential.

• Excellent interpersonal, written, and oral communication skills.

• Remarkable organizational abilities.

• Capable of thriving in a fast-paced, multi-disciplinary industrial setting.

• Comfortable with generally receiving no instructions on routine tasks and general guidance on new assignments.

• Familiarity with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is advantageous.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off