Sr. Manager Quality Systems
Summary
The Sr. Manager of Quality Systems will plan, coordinate, and direct the GSMS Quality Systems program to ensure continuous production of products consistent with U.S. regulatory requirements and GSMS policies and procedures. The Sr. Manager Quality of Systems is responsible for Investigations, CAPA, Change Control, Document Management, Specifications, Training, Product Stability, Validation Program, Supplier Quality Performance, Product Complaints/Adverse Events, Recalls, Management Review, Annual Product Review, Internal Audits, Inspection Management, as well as Quality System monitoring, trending, and reporting.
Experience:
Bachelor’s degree with a minimum 10 years of experience in pharmaceutical operations, medical device, or other related industry is required, and 5 years of managing experience.
General Duties and Responsibilities:
• Ensures quality system processes and activities are designed and performed in adherence to FDA cGMP’s.
• Formulates and maintains Quality objectives and coordinates objectives with other operations departments to maximize product quality and reliability and to minimize costs.
• Reports on key quality indicators to the Extended Leadership Team.
• Manages directly and indirectly, quality systems staff. Performs goal setting and performance reviews per GSMS policies.
• Leads the development of training plans and conducts training of personnel as necessary.
• Drives a culture of continuous improvement.
• Responsible for the design, execution, monitoring and improvement of the Quality Management System.
• Leads the development, monitoring and improvement of the Quality Management System metrics and reporting processes.
• Responsible for the Quality System Management Review process.
• Responsible for the Deviation/Investigation program and processes.
• Responsible for Corrective Action/Preventive Action program.
• Responsible for GSMS Product Stability program.
• Responsible for component & product specifications.
• Responsible for quality oversight for GMP related master data in GSMS’ ERP system (BOM Approval, etc.)
• Responsible for the Validation Program and related documentation.
• Responsible for Change Control process for product, process, equipment, facility, and procedural changes.
• Responsible for the GSMS GMP Training Program.
• Responsible for the Product Complaints, Adverse Events, Product Recalls and Product Returns programs and processes.
• Responsible for the Annual Product Review program and execution of related processes.
• Responsible for supplier quality performance, supplier change notices, and supplier corrective action requests.
• Responsible for internal audit programs and execution of internal audits.
• Responsible for management of regulatory and 3rd party inspections and inspection responses.
• Performs vendor, manufacturer, and internal audits as requested.
• Performs other quality and compliance-related duties as assigned.
Equipment:
Standard office equipment, computers, full-body suit, goggles, cap, booties, gloves, and respirator.
Physical/Cognitive Requirements:
• Thorough knowledge of FDA GMP regulations and quality system regulations/requirements
• In-depth knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control).
• Quality auditing experience.
• Excellent data trending and analysis skills, with the ability to identify necessary remediation actions.
• Excellent communication skills at all levels, both written and verbal; both individually and in a group setting.
• Excellent skills in analytical thinking and problem solving.
• Ability to perform multiple tasks and ability to effectively manage conflict.
• Ability to work in teams to obtain results.
• Proactively identify issues and acting.
• Excellent decision-making skills. Ability to make decisions with limited information.
• Effectively manage change and comfortable changing direction and acting without complete information.
• Excellent organizational and prioritization skills.
• May be required to work longer than the typical 8-hour workday.
• Primarily sedentary position that requires 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.
Computer Skills:
• Required working knowledge of basic Microsoft Office applications. More advanced knowledge of data analysis software and reporting (e.g., Excel, etc.).
• Strong internet research skills are required.
Miscellaneous Requirements:
• Maintain a strong attendance record.
• Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
Attitude:
• 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 flexible and willing to change.
• Must be detail oriented.
• Team player, professional, and achieve high quality results.
“At Golden State Medical Supply (GSMS), we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at [email protected]. GSMS will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.”