Senior Quality Assurance Manager - BioScience

About the role

The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section. Step Into a High-Impact Role in Quality Assurance!

Responsibilities

• 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.
• 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.
• 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.
• Aid in the preparation and presentation of the Annual Product Review to the Quality Review Board.
• 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.
• 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.

Requirements

• 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.

Qualifications

• Detail-Oriented Problem Solver – Able to spot quality issues early and implement smart, sustainable solutions.
• Exceptional Communicator – Strong written and verbal communication skills, essential for audits, reporting, and cross-team collaboration.
• QMS & Tech Proficiency – Experience with digital quality systems like TrackWise Digital or similar platforms.
• Team Player with Leadership Drive – Comfortable managing multiple priorities in a collaborative, fast-paced environment.
• Analytical Thinker – Brings logic, critical thinking, and data-driven decision-making to every challenge.

Skills & Competencies

• Detail-Oriented Problem Solver – Able to spot quality issues early and implement smart, sustainable solutions.
• Exceptional Communicator – Strong written and verbal communication skills, essential for audits, reporting, and cross-team collaboration.
• QMS & Tech Proficiency – Experience with digital quality systems like TrackWise Digital or similar platforms.
• Team Player with Leadership Drive – Comfortable managing multiple priorities in a collaborative, fast-paced environment.
• Analytical Thinker – Brings logic, critical thinking, and data-driven decision-making to every challenge.

Benefits

At Smithfield Foods, we offer a comprehensive benefits package designed to support you and your family. This includes:

• Health insurance options
• Paid time off
• Retirement savings plans
• Employee assistance programs
• Professional development opportunities

Pay

The expected pay range for this position is $120,000 - $162,500 annually.

Schedule

Full-time position available.