Quality & Compliance Manager

Experience: Minimum 8+ years in pharmaceutical operations required. High School Diploma required. Bachelor’s degree preferred, health sciences preferred.

The Quality & Compliance Manager will lead the development, management, and execution of the supplier quality management, internal audit & inspection readiness, and CAPA programs s role is responsible for supplier quality management of suppliers that provide raw materials, drug products, and GMP services to GSMS; the GSMS internal audit and inspection readiness program; and the GSMS CAPA prograom. This role oversees supplier qualification & performance, external & internal audit strategy, compliance with FDA regulations, and CAPA monitoring & effectiveness.

• Responsible for the development and execution of the supplier quality management program and processes for GMP suppliers.
• Manage the quality of drug product, raw material, and GMP service suppliers to ensure GSMS and FDA requirements are met
• Qualify new suppliers per GSMS policies and procedures.
• Negotiate, approve and manage quality agreements between GSMS and suppliers
• Participate on a cross functional supplier management team with colleagues from Supply Chain, Purchasing, and Commercial Operations to assess, communicate, and manage supplier performance via scorecards and business meetings
• Develop and maintain supplier risk ranking including evaluating internal and supplier Preventive Controls
• Oversee the Supplier Change Notification (SCN) process, ensuring GSMS is notified of supplier changes and GSMS processes & procedures are thoroughly assessed and updated as required.
• Work collaboratively with suppliers and GSMS Quality teams on Supplier Corrective Action Request (SCAR) process, ensuring effective corrective actions are being taken by suppliers.
• Develop and maintain a current and accurate database of supplier quality management information such as Supplier History File, Approved Vendor List (AVL), risk analysis results, supplier performance, etc.
• Develop and manage GSMS external and internal audit programs.
• Oversee and conduct external and internal audits, ensuring any improvements or corrective actions are addressed to GSMS’s satisfaction.
• Manage GSMS CAPA program. Lead CAPA meetings and monitor timeliness & effectiveness of correction actions.
• Helps drive a culture of continuous improvement.
• Assist with leading regulatory and 3 rd party inspections and audits, including pre-inspection readiness, inspection execution, and post inspection responses.
• Performs other quality and compliance-related duties as assigned.

Received:
Directives from Director, Quality & Regulatory Compliance

Given: N/A

Standard office equipment, computers, safety glasses, cap, booties, gloves, as required.

• Strong knowledge of FDA GMP regulations, practices and trends.
• Working knowledge of pharmaceutical processing and manufacturing processes.
• Strong communication skills at all levels, both written and verbal; both individually and in a group setting.
• Strong leadership, negotiation and influencing skills
• Strong skills in analytical thinking and problem solving.
• Proficiency in audit planning, execution, and reporting.
• Ability to translate complex data into actionable information
• Ability to evaluate complex compliance issues and concerns
• Ability to perform multiple tasks and ability to effectively manage conflict.
• Ability to work in teams to obtain results.
• Good decision-making skills. Ability to make decisions with limited information.
• Proactively identify issues and take action.
• Effectively manage change and comfortable changing direction and acting without complete information.
• Good organizational and prioritization skills.
• May be required to work longer than the typical 8-hour work day.
• Sedentary position that may requires pro-longed long periods of desk work.
• Requires light physical duties in keeping work areas clean and organized. Regularly required to walk the production and warehouse areas.

• Required working knowledge of basic Microsoft Office applications.
• Working knowledge of data analysis software and reporting.
• Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
• Travel 25-30% domestic to supplier locations.
• Must be enthusiastic, concerned with job and company as whole, openness with management, and punctual.
• Self-discipline and a desire to achieve results.
• Must be detail-oriented.
• Team player, professional, and achieve high quality results.

The hiring range for this position in Camarillo, CA is $85,000 to $115,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills and experience among other factors. A bonus may be provided as part of the compensation package, in addition to a full range of other health and welfare benefits.