Headquartered in Pomona, California, Med-Pharmex, Inc. is among the leading developers and manufacturers of generic veterinary pharmaceutical products in the U.S. The Company markets over 25 FDA-approved products, all manufactured in one of its three FDA-approved, Pomona-based facilities, with multiple drug delivery systems such as injectables, suspensions, oral solutions, sprays, ointments, creams, pastes, and powders. Utilizing its expertise and experience in pharmaceutical product development in a cGMP environment, the Company’s strength lies in its ability to continually innovate and develop products with high barrier entry, successfully navigate FDA regulatory requirements, and bring quality generic drug products to the veterinary market.
The Sr. Quality Management Systems (QMS) Manager oversees and actively participates in all aspects pertaining to Deviations, Investigations, Complaints, and CAPA. The Sr. QMS Manager must be able to thoroughly and accurately complete/assist in the investigation of incidents / events which have occurred during the manufacturing, packaging, testing and storage of pharmaceutical products for determination of root cause and product impact per FDA regulations. In addition, he/she ensures that corrective and preventive actions (CAPA) based on investigation findings are identified and implemented to prevent occurrence/reoccurrence of the events. The Sr. QMS Manager will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Director of QA and Compliance.
Duties and Responsibilities:
- Review and/or conduct thorough investigations and act as the Investigation Team Lead for Incidents/Deviations, OOS Investigations, Laboratory Events and Product Complaint Investigations as required following appropriate company procedures.
- Ensure all investigations are completed in a timely manner to support product release and regulatory compliance
- Ensure that all Incidents/Deviations, OOSs, Laboratory Events and Product Complaints are documented and tracked according to procedures.
- Identify and oversee the implementation of the appropriate corrective and preventive actions (CAPA) to prevent occurrence/reoccurrence.
- Provide guidance to other departments and serve as subject matter expert (SME) on the performance of investigations and in the use of Root Cause Analysis Tools
- Manage CAPAs to ensure timely closure of actions resulting from various types of investigations.
- Provide metrics as requested to track/trend Incident, Event/Deviations, CAPA and Complaints.
- Manage Effectiveness Checks to ensure they are completed by the required due date and perform closure of Effectiveness Checks.
- Provide training on conducting investigations and performing root cause analysis as needed.
- Assist during regulatory inspections or other audits, as required
- Maintain knowledge of current regulatory requirements pertaining to pharmaceutical products
- Initiate SOP revisions as needed to assure compliance and continuous improvement.
- Maintain effective communication and partnership with all departments across the organization
- Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations.
- Generate and facilitate changes to SOPs, policies, training materials, and other documents.
- Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures.
- Assist staff regarding QMS processes.
- Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues.
- Proactive, good organizational and time management skills.
- Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management.
- Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested.
- Interact with other departments to resolve any issues regarding QMS documents.
- Other duties may be assigned by the Director of QA and Compliance.
- Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred.
- Minimum of five (5) years of experience working in a Pharmaceutical GMP environment.
- Minimum of five (5) years of experience in a QA and/or QS role in a pharmaceutical manufacturing environment.
- Lean, Six Sigma and cGMP experience preferred.
- Proficiency in Microsoft Office particularly in Excel, PowerPoint, and Word. LIMS systems and ComplianceWire experience is a plus.
- Strong organizational skills and the ability to multitask.
- Demonstrated ability in working independently and as part of a team.
- Must be able to work in a cross-functional environment interacting with other internal departments and external vendors.
- Excellent communication (oral and written) and interpersonal skills.
- Must be able to communicate technical, scientific, and regulatory information, both written and verbally.
- Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance.
Position type/Expected Hours of Work
This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
Med-Pharmex is an equal opportunity employer and prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender (including gender identity and gender expression), medical condition, genetic information, marital status, national origin, mental and physical disability, military and veteran status, or any other characteristic protected by law.