Quality & Compliance Manager

GSMS•Camarillo, CA

4h•$85,000 - $115,000

About The Position

The Quality & Compliance Manager will lead the development, management, and execution of the supplier quality management, internal audit & inspection readiness, and CAPA programs at GSMS. This 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.

Requirements

Minimum 8+ years in pharmaceutical operations required.
High School Diploma 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.

Nice To Haves

Bachelor’s degree preferred, health sciences preferred.

Responsibilities

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.