Senior Quality Engineering Manager

Role Title: Senior Quality Engineering Manager
Department: Quality
Supervisor: Senior Director, Quality
FLSA: Exempt

CORE VALUES

Respect Passion Teamwork Integrity Honesty Commitment Collaboration

FUNCTION SUMMARY Sr. Quality Engineering Manager

The Senior Quality Engineering Manager is responsible for ensuring that quality requirements for manufacturing equipment, processes, analytical equipment and procedures associated with commercial biopharmaceutical production are established, maintained, and executed in accordance with the appropriate regulations and cGMP guidelines. Will provide quality in the plant support within a highly collaborative and cross-functional environment ensuring product quality, compliance, and customer satisfaction for both in-house and CDMO products. Responsibilities include quality strategic input, review, and approval of Quality Assurance documentation including the following: Technical Reports; Method; Process; Equipment Validation; Change Controls; and all Deviations requiring Quality Assurance oversight. The ideal candidate will apply strong collaborative leadership and cGMP experience, ensuring compliant operations and documentation, foster open communication, and pursue data-driven approaches.

Duties & Responsibilities:

1. Support ensuring Polaris quality requirements are compliant with the appropriate regulations by various regulatory bodies/entities.
2. Management of Quality required Change Controls and Deviations supporting analytical methods, manufacturing processes, process/analytical equipment, and Quality systems.
3. Provide SME strategic leadership to support the overall business strategy for QA & QC in maintaining on time delivery of Quality deviations, investigations, CAPA's and associated documents to support the master production schedule and PAI readiness.
4. Partner with cross functional partners to support generation, review, and periodic review of site Master Validation Plan(s) and associated validation documentation.
5. Provide leadership and strategic oversight for multi-variate investigations at the site, including resolution strategies, CAPA implementation, and Material Review Board decisions.
6. Provide SME Quality person in the plant support during routine commercial operations.
7. Responsible for organizing routing Material Review Board meetings for change controls and deviations, and compiling and reporting on the performance of the quality system. Collaborate with cross functional partners to prepare comprehensive MRB material and metrics.
8. Keep up to date of current Quality Standards and Regulations impacting the biopharmaceutical industry.
9. Support the review stability data and associated statistical analysis and stability reports.
10. Holds self and others responsible to abide by department and Company policies and practices.

Skills & Competencies

• Ability to lead complex investigations involving multiple functions.
• Ability to gain consensus on key quality/operational decisions.
• Strong analysis/problem solving, failure analysis, and risk analysis skills.
• Strong attention to detail/quality focus.
• Ability and willingness to provide leadership to the entire group, with proficiency in both facilitating active and open discussion, and laying groundwork for logical decision making.
• Ability and willingness to collaborate with and influence other groups in a positive, team-based environment. Must also be able to hold others to account as required.
• Work with a sense of urgency and have the ability to be impartial and objective.
• Maintain ability and willingness to engage in active and open discussion, laying groundwork for logical decision making, in any assigned quality task.
• Excellent communication skills (both written and verbal), excellent interpersonal and presentation skills and be team focused.
• Excellent organizational skills.
• Be an active learner and developer of self and others.

Education & Experience

• B. S./B. A. in Science/Related Field (major in engineering or an alternative biology-biochemistry-chemistry degree program with certification as a quality engineer CQE). 10+ years of relevant management experience in a biopharmaceutical quality field is desired.

• MS Degree in Science/Related Field (major in engineering or an alternative biology-biochemistry-chemistry degree program with certification as a quality engineer CQE). 7+ years of relevant management experience in a biopharmaceutical quality field is desired.

• PhD in Science/Related Field (major in engineering or an alternative biology-biochemistry-chemistry degree program with certification as a quality engineer (CQE). 5+ years of relevant management experience in a biopharmaceutical quality field is desired.

• Minimum 5+ years of leadership experience including the supervision of direct reports is required.

• In-depth working knowledge of International Standards, GDP, GLP, and GMP.

• Experience with cGMP validation, clean room operations, analytical, and environmental monitoring/analysis preferred.