Senior Quality Assurance Manager - BioScience

Quality Assurance Leader

Ready to make a real difference in the world of pharmaceutical and medical device manufacturing? Smithfield BioScience, Inc. (SBC) is seeking a quality-driven professional for a full-time role reporting to the Head of Qualitya position that sits at the heart of our mission to deliver products that meet the highest global standards.

As a Quality Assurance leader, you'll be on the front lines of enforcing current Good Manufacturing Practices (cGMP) and safeguarding the integrity of our quality management systems. You won't just be checking boxesyou'll be shaping the standards that ensure our FDA-registered facility operates with unmatched precision and compliance.

Your oversight will be critical to the manufacture of high-quality Active Pharmaceutical Ingredients (APIs) and medical device components, all in accordance with 21 CFR Parts 210/211, ICH Q7, ISO 22442, and EU regulatory guidelines. You'll own system controls, uphold procedural excellence, and be a key driver of continuous improvement and operational readiness.

If you're passionate about compliance, thrive in a fast-paced regulated environment, and are ready to lead with confidencethis is the opportunity for you.

What You'll Do

The below statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.

Quality Assurance Leadership

• Lead and manage the QA team to ensure full compliance with cGMP standards and adherence to internal SOPs.
• Provide strategic direction and decision-making on all quality-related matters, acting as a go-to leader during escalations.
• Champion a culture of quality-first thinking, driving operational excellence across departments.

Process Development & Continuous Improvement

• Collaborate in the design, development, and refinement of quality systems, procedures, and product processes.
• Drive continuous improvement initiatives across QA operations to streamline workflows and elevate product quality.
• Coordinate with Regulatory Affairs to assess the impact of critical change control activities on customer satisfaction and compliance.

Data Management & Reporting

• Ensure accurate recordkeeping, archival, and retrieval of all QA-related data, supporting traceability and audit-readiness.
• Compile and present quality metrics and key performance indicators (KPIs) to senior management for informed decision-making.
• Assist in preparation and presentation of the Annual Product Review to the Quality Review Board.

Regulatory Compliance & Inspection Readiness

• Maintain the facility in a constant state of readiness for FDA, EU, and other regulatory inspections.
• Actively participate in internal audits, customer audits, and regulatory inspections, demonstrating a deep understanding of applicable standards.
• Stay current with evolving FDA, EU, and ICH regulations, ensuring company procedures remain aligned with global expectations.

Quality Systems Oversight

• Oversee and safeguard company Quality Management System (QMS) records to ensure accuracy, security, and compliance.
• Ensure timely and thorough investigations of OOS (Out of Specification) results, CAPAs, complaints, and deviations, all in accordance with FDA guidelines.
• Collaborate cross-functionally to support the validation of company processes, test methods, and computerized systems.

Skills & Competencies

• Detail-oriented problem solverable to spot quality issues early and implement smart, sustainable solutions.
• Exceptional communicatorstrong written and verbal communication skills, essential for audits, reporting, and cross-team collaboration.
• QMS & Tech Proficiencyexperience with digital quality systems like TrackWise Digital or similar platforms.
• Team Player with Leadership Drivecomfortable managing multiple priorities in a collaborative, fast-paced environment.
• Analytical Thinkerbrings logic, critical thinking, and data-driven decision-making to every challenge.

What We're Seeking

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

• Bachelor's degree from an accredited four-year college or university in a chemistry, microbiology or other relevant technical field and 8+ years of relevant manufacturing experience, or an equivalent combination of education and experience, required.
• Minimum 2 years of demonstrated experience in team management/development or project leadership is required preferably in pharmaceutical cGMP manufacturing.
• Candidates with a Master's Degree in a Science or Technical field from an accredited four-year college or university and 6+ years relevant experience will be considered qualified.
• In-depth knowledge of relevant regulations and standards in the pharmaceutical industry (e.g., 21 CFR Part 210/211, ICH Q7, 21 CFR Part 11).
• Strong understanding of Good Manufacturing Practices (GMP) and their application in the pharmaceutical industry.
• Experience in developing, implementing, and maintaining a quality management system.
• Experience in conducting internal and external audits and managing audit programs.
• Proficient with the TrackWise QMS modules for Quality Events, CAPA, OOS, and Audit (or equivalent eQMS system).
• Familiarity with risk management principles and tools, including FMEA (Failure Modes and Effects Analysis) and risk assessment methodologies.
• Excellent analytical, problem-solving, and root cause analysis skills, with the ability to apply data-driven decision-making.
• Strong written and verbal communication skills, with the ability to effectively interact with cross-functional teams, regulatory authorities, and external stakeholders.
• Relevant certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt are advantageous.

Relocation Package Available No

EEO Information

Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.