Overview
Quality Operations Leader Jobs in United States at Confidential
Title: Quality Operations Leader
Company: Confidential
Location: United States
On-site at a Midwest manufacturing facility – Excellent relocation package available!
This position provides strategic, technical, and regulatory leadership for the Quality function at a pharmaceutical manufacturing facility. The role oversees all activities related to Product Quality, Compliance, and Quality Systems while also partnering with R&D to support the development, launch, and commercialization of new products.
Responsibilities:
Oversee and guide Quality Assurance and Compliance initiatives, along with Quality Control testing facilities, to support global product launches, manufacturing, and distribution. Partner with the Site Leadership Team to foster continuous improvement by creating and executing a comprehensive Quality Plan.
Lead the Operations Unit in executing quality policies, strategies, systems, and procedures to ensure the purity, efficacy, safety, and potency of all products manufactured or tested at the facility. Guarantee thorough root cause investigations and implementation of effective CAPAs to address issues impacting product quality or regulatory compliance.
Act as the primary leader for regulatory inspections at the site. Ensure adherence to all regulatory standards regarding product quality and operational compliance through the application of relevant requirements and workforce training initiatives.
Approve and authorize site-specific processes, including testing, inspection, and release of raw materials, packaging components, labeling, and finished products. Oversee product and process validations, quality documentation, and decisions on product releases, recalls, and market withdrawals.
Strengthen the organization’s technical expertise and capabilities in Biotech manufacturing. Identify high-potential individuals for succession plans and develop a team of technical Quality future leaders.
Minimum qualifications:
Bachelor’s degree in science related field.
10+ years of experience in pharmaceutical production with increasing responsibilities in Quality Assurance.
5+ years of experience in people management including direct & indirect reports.
Thorough knowledge of cGMP regulatory requirements, including direct experience with external audits.
