Corporate Quality Assurance Consultant

The Steely Group; Jersey City (NJ); Hybrid; USD 83.000 - 124.000; Teilzeit

Benefits dieser Stelle

Remote work

Zusammenfassung

The Steely Group is seeking an experienced Corporate Quality Assurance Consultant to oversee and strengthen the company's Quality Management System (QMS), SOP governance, internal audits, and quality training.

This part-time remote engagement focuses on BARDA-related QA activities, Quality Agreements, and alignment with GxP principles, collaborating with CMC QA and functional leaders to build a compliant quality infrastructure.

Qualifikationen

• Bachelor's degree in life sciences, pharmaceutical sciences, engineering, or related discipline.
• Approximately 10+ years of Quality Assurance experience in pharma/biotech.
• Expertise in developing, administering, and improving QMS.
• Strong knowledge of GxP principles for clinical-stage drug development.
• Experience building SOPs, internal audit programs, training, and QMRs.
• Experience developing and maintaining Quality Agreements with vendors.
• Experience supporting BARDA or government-funded programs preferred.
• Ability to translate quality requirements into pragmatic processes for a small biotech.

Aufgaben

• Oversee the administration, maintenance, and continuous improvement of the company's QMS.
• Lead SOP governance and lifecycle management with functional SMEs.
• Develop and coordinate risk-based internal audit plans and audits.
• Oversee corporate quality training and track completion.
• Coordinate periodic Quality Management Reviews and report trends.
• Establish and maintain Quality Agreements with third-party vendors.
• Provide BARDA quality support, plans, and documentation.

Kenntnisse

Quality Assurance

QMS development

GxP knowledge

SOPs & internal audits

Quality training

Regulatory audit readiness

Communication

Independent work

Ausbildung

Bachelor's degree in life sciences, pharmaceutical sciences, engineering, or related discipline

Jobbeschreibung

Part‑Time (15 hours per week) | Remote

Our client is seeking an experienced Corporate Quality Assurance Consultant to provide hands‑on oversight and management of the Company's corporate Quality Management System (QMS).

This individual will be responsible for maintaining and strengthening corporate quality systems, including SOP governance, internal audits, quality training, Quality Management Reviews, and other quality processes necessary to support a compliant and effective organization. The consultant will also support corporate quality requirements associated with BARDA-funded activities, including quality planning, audit readiness, Quality Agreements, and related documentation. This role will partner closely with functional leaders, including CMC Quality Assurance, while maintaining a distinct focus on corporate quality systems, governance, and compliance infrastructure.

Key Responsibilities

• Quality Management System Oversee the administration, maintenance, and continuous improvement of the Company's Quality Management System (QMS). Ensure corporate quality processes and documentation are appropriate for the Company's stage of development and evolving business needs. Assess the effectiveness of existing quality systems, identify gaps, and implement practical, scalable improvements. Establish and maintain appropriate corporate QA processes, tools, documentation, and metrics.
• SOP & Document Governance Lead the development, review, revision, implementation, and lifecycle management of corporate Standard Operating Procedures (SOPs) and related controlled documents. Partner with functional subject matter experts to ensure SOPs accurately reflect company practices and applicable requirements. Maintain a process and schedule for periodic review and updating of SOPs and other controlled documents. Ensure appropriate documentation and version control within the corporate quality system.
• Internal Audit Develop and maintain a risk-based internal audit plan and schedule. Conduct or coordinate internal audits to assess adherence to company SOPs, quality processes, and applicable requirements. Document audit findings and track resulting corrective actions through resolution. Maintain audit documentation and support inspection and audit readiness from a corporate QMS perspective.
• Quality Training Oversee the Company's corporate quality and compliance training program. Coordinate training associated with new and revised SOPs and controlled documents. Maintain training records and monitor completion of required quality training. Work with functional leaders to identify appropriate quality training needs.
• Quality Management Review Establish, coordinate, and facilitate periodic Quality Management Reviews. Develop and maintain appropriate QMS metrics and reporting. Present trends, key quality issues, audit findings, training status, and areas requiring management attention. Track agreed actions and quality-system improvements resulting from management reviews.
• Quality Agreements & Vendor Quality Governance Establish and maintain the Company's overall framework and standards for Quality Agreements with third-party vendors. Coordinate with functional owners, including CMC Quality Assurance, to ensure appropriate Quality Agreements are in place and maintained for applicable vendors. Periodically review existing Quality Agreements and coordinate updates based on changes in company requirements, contractual obligations, or applicable quality expectations. Maintain centralized oversight of Quality Agreement status and documentation.
• BARDA Quality Support Provide corporate QA support for quality-system requirements associated with BARDA-funded activities. Develop and maintain applicable BARDA-related quality plans, audit plans, and corporate quality documentation. Review existing corporate quality processes and documentation for alignment with applicable BARDA contractual quality requirements. Coordinate updates to applicable Quality Agreements to reflect BARDA-related quality expectations, working with the appropriate functional and CMC Quality owners. Support quality documentation and preparedness for BARDA reviews, audits, or other quality oversight activities. Partner with internal stakeholders to help ensure BARDA-related quality commitments are appropriately incorporated into the corporate QMS.

Qualifications

• Bachelor's degree in life sciences, pharmaceutical sciences, engineering, or a related discipline.
• Approximately 10+ years of Quality Assurance experience within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in the development, administration, and continuous improvement of Quality Management Systems (QMS).
• Strong knowledge of GxP quality principles and quality systems applicable to clinical-stage drug development organizations.
• Significant experience developing and managing SOPs, internal audit programs, quality training programs, Quality Management Reviews, and controlled documentation.
• Experience developing, reviewing, and maintaining third-party Quality Agreements.
• Experience preparing for and supporting regulatory, partner, sponsor, or government audits and quality reviews.
• Previous experience supporting BARDA or other U.S. government-funded drug-development programs preferred.
• Ability to translate quality and contractual requirements into pragmatic processes appropriate for a small biotechnology company.
• Strong organizational, written, and interpersonal communication skills.
• Demonstrated ability to operate independently and effectively manage priorities within a part-time consulting engagement.

Engagement

Part-time consulting engagement of approximately 10-15 hours per week. Hours may vary based on quality-system priorities, audit activities, and BARDA-related requirements. The consultant will partner with internal functional leaders and external partners while maintaining primary responsibility for the Company's corporate QMS and quality governance infrastructure.