Sr. Quality Systems Engineer

Interview Process: Two Step Interview Process. First interview will be virtual via Microsoft Teams. Second interview will be in person, on-site, including a facility tour.

Core Essential Skills Minimum 5 years of experience:

1. Quality Systems and GMP/Compliance experience within a pharmaceutical manufacturing environment
2. Change Control and Quality Documentation Management
3. Review and Approval of SOPs, Protocols, Risk Assessments, and Quality Records
4. Independent Problem-Solving, Sound Judgment, and Decision-Making
5. Strong Technical Writing and Cross-Functional Communication Skills
6. Candidates should be senior-level, independent, motivated, and comfortable making higher-level decisions.

7. Experience with compliance or quality systems, documentation review and approval, and strong technical writing skills. Management experience is not required.

POSITION SUMMARY

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. This position ensures adherence to quality standards, policies and procedures, while facilitating improvements and building a collaborative team environment among internal and external stakeholders. This position represents Quality Systems leadership and interacts closely with other areas such as Operations, Manufacturing Science and Technology, Research and Development, Supply Chain and Quality Control.

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality / Compliance program related projects as required.
• Responsible for hosting the Change Control Review Board and overseeing change control activities from initiation through implementation and approval.
• Responsible for providing records management and change control expertise to support compliant shutdown planning and execution.
• Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
• Responsible for participating in partner, internal and regulatory inspections and audits as needed.
• Responsible for reviewing and approving standard operating procedures, protocols, risk assessments and other quality records, as needed.
• Responsible for improving and maintaining quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.
• Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP).
• Responsible for performing additional related duties as assigned.

POSITION REQUIREMENTS

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Bachelor's Degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical industry.
• Requires a 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/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, as well as 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.

• Ability to communicate effectively with 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 the business objectives.
• Ability to understand inter-department linkages and alignment of own department with other departments.
• Ability to drive change by identifying areas for improvement, engaging and motivating others and working through difficult transitions.

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.