Quality Assurance Manager

About the role

The Quality Assurance Manager supports the strategic direction to ensure business objectives are met. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, Compendia management and CAPA.

Responsibilities

• Supports the strategic direction to ensure business objectives are met.
• Provides direction to staff of professionals to include hiring, setting performance expectations, performance feedback and development of staff.
• Directs the development of Quality policies that meet both regulatory and company requirements.
• Maintains expertise on various regulations (FDA, EMA, ICH, etc.).
• Translates strategy into tactical objectives to deliver strategic plans and regulatory updates.
• Ensures all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
• Provides compliance leadership to the manufacturing site.
• Provides direct interface with FDA and other regulatory agencies and customers during inspections.
• Assesses compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Reviews and approves deviation investigations, driving reduction in quality events through robust CAPA.
• Compiles, analyzes and communicates significant quality or compliance metrics to senior management.
• Establishes programs to promote quality awareness and compliance.

Requirements

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
• 8+ years’ experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and in leading cross-functional teams.
• Techical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently.
• Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) and written communication skills needed.
• Excellent interpersonal skills a plus.
• Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
• 8+ years’ experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and in leading cross-functional teams.
• Techical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently.
• Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) and written communication skills needed.
• Excellent interpersonal skills a plus.
• Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

Skills

• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently.
• Strong oral (with all levels of management) and written communication skills.
• Excellent interpersonal skills.
• Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

Benefits

• Paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) plan.

Pay

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

Schedule

This job is eligible to participate in our long-term incentive programs.