Senior Director, Quality Operations

Alternative Resources Company, an Openwork Company; North Carolina; On-site; USD 180,000 - 190,000; Full time

Job summary

Alternative Resources Company, an Openwork Company, seeks a senior quality leader to guide QA and regulatory affairs in a pharmaceutical manufacturing environment. You will set strategic direction for Quality Assurance, Quality System, and Quality Control, mentoring staff and directing audits and inspections.

Key responsibilities include overseeing analytical and microbiology labs, ensuring cGMP compliance, and coordinating regulatory interactions with FDA.

Qualifications

• 15+ years pharmaceutical quality experience in manufacturing, CMO, or life sciences tech.
• Analytical and microbiology proficiency for semi-solid drug products.
• Extensive experience with cGMP and regulatory compliance requirements.
• Proven leadership of quality and analytical teams and strategic growth initiatives.
• Experience across the product development lifecycle from concept to validation.
• Ability to lead, influence and work in cross-functional teams.

Responsibilities

• Provide leadership and direction to the Quality organization.
• Mentor, oversight and development for QA, Quality System, QA staff.
• Make decisions on key quality-related strategic and operational matters.
• Direct and control activities and outcomes of Quality Assurance.
• Set and align goals for QA with corporate objectives.
• Oversee regulatory inspections with FDA or other agencies.
• Develop and maintain external relationships with key officials.
• Direct development of systems to review design/manufacturing changes.
• Provide leadership for significant deviation events affecting compliance or risk.
• Oversee laboratories (analytical/microbiology), release testing, stability, environmental monitoring.
• Review and approve quality documents (deviations, OPRs, complaints, validation, change controls).

Skills

Quality Leadership

Regulatory Compliance

Cross-functional Leadership

Strategic Planning

FDA/Regulatory Inspections

Analytical & Microbiology

Education

Bachelor’s Degree or higher in life sciences, engineering, or business

Job description

Support quality initiatives and ensure compliance with cGMP’s are maintained at the facility.

Responsibilities

• Provide leadership and direction to the Quality organization.
• Provide mentorship, oversight and development for the Quality Assurance, Quality System, Quality Affairs, and Quality Control staff.
• Make decisions on key quality-related strategic and operational matters that have a significant, direction-setting impact on the company.
• Direct and control the activities and outcomes of Quality Assurance which has a significant organizational and product impact.
• Set and align goals and objectives for the Quality Assurance department with the overall corporate goals and objectives.
• Oversee preparation, coordination and execution of all regulatory inspections with the FDA or other regulatory agencies.
• Develop and maintain external relationships with key opinion leaders and regulatory officials.
• Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/ or manufacturing changes.
• Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk.
• Oversee the functions of the analytical and microbiology laboratories, including: raw material and component release, in-process testing, finished product release testing, stability testing, and environmental monitoring.
• Review and approve quality documents, including: deviations, annual product quality reviews, customer complaints, validation protocols/reports, and change controls.

Qualifications

• Bachelor’s Degree or higher in life sciences, engineering, or business.
• 15+ years pharmaceutical quality experience in a manufacturing, CMO, or life sciences technology driven company.
• Analytical and Microbiological proficiency related to the methodology of semi-solids drug products and associated excipients.
• Extensive experience in cGMP and other Regulatory compliance requirements.
• Progressive, proven track record of leading quality and analytical organizations and establishing long-term strategic growth initiatives.
• Experience with phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization.
• Ability to lead, influence, create and work within cross-functional team environments.

Base salary range: $180,000 - $190,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.