Sr. Quality Systems Engineer

Pay

40‑50 /hr depending on experience

About the role

This position is responsible for providing support for the quality management systems (QMS), including documentation management, Continuous Improvement program, process, cleaning and computer system validation, equipment, facility and utility qualification. The role oversees Change Management, Annual Product Review, and Metrics and Data Trending. It ensures adherence to quality standards, policies and procedures, while facilitating improvements and building a collaborative team environment among internal and external stakeholders. The position represents Quality Systems leadership and interacts closely with Operations, Manufacturing Science and Technology, Research and Development, Supply Chain and Quality Control.

Responsibilities

• Develop, support and execute annual projects to deliver on‑site metrics, KPIs, goals, and other Quality/Compliance program‑related projects as required.
• Host the Change Control Review Board and oversee change control activities from initiation through implementation and approval.
• Provide records management and change control expertise to support compliant shutdown planning and execution.
• Ensure efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
• Participate in partner, internal and regulatory inspections and audits as needed.
• Review and approve standard operating procedures, protocols, risk assessments and other quality records, as needed.
• Improve and maintain quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.
• Support Quality projects for accomplishment of organization goals, including corporate standard assessments, Quality project team meetings, and other cross‑functional site initiatives.
• Complete all training requirements and maintain compliance with all assignments.
• Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies, Good Manufacturing Practices (CGMP) and Standard Operating Procedures (SOP).
• Perform additional related duties as assigned.

Requirements

• Bachelor’s degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience.
• Minimum of 7 years relevant progressive experience in the pharmaceutical industry.
• Minimum of 3 years’ experience in Quality Assurance within pharmaceutical production.
• Prefer direct experience with the manufacturing of various pharmaceutical dosage forms.
• Prefer direct experience with Health Authority inspections (FDA/EMA, ANVISA, etc.).
• Project management and advanced presentation skills preferred.

Skills

• Computer proficiency with comprehensive working knowledge of MS Office, Learning Management Systems (LMS), EDMS, ERP systems, and Quality systems such as Trackwise and Veeva.
• Self‑directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Ability to demonstrate sound judgment and decision‑making.
• Excellent written and oral communication skills.
• Ability to interact positively and collaborate with co‑workers, management and external partners.
• Ability to analyze information and create metrics relevant to business objectives.
• Understanding of inter‑department linkages and alignment of own department with others.
• Ability to drive change by identifying improvement areas, engaging and motivating others, and navigating difficult transitions.

Problem Solving

• Proactively works on complex‑scope problems requiring analysis of contributing factors and in‑depth knowledge of known and unknown variables.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to direct methods and procedures for problem resolution.

Travel Requirements

Minimal, frequent travel.

Physical Requirements

• Sitting for extended periods of time.
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive motions – frequent motions of the wrists, hands and/or fingers.
• Occasional standing for extended periods at work stations or equipment.
• Walking to move short distances quickly and frequently.
• Lifting – raising objects from lower to upper and/or moving objects horizontally, up to 25 lb.
• Close visual acuity for computer work, data analysis, extensive reading.
• Frequent exposure to low to moderate noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• May be required to wear personal protective equipment (PPE) such as safety glasses, hearing protection, gloves, etc., when in production areas.