Quality Director
- $155,000 - $170,000
- Pasadena, CA
Come join a company where you can influence change and make a difference!
A bit about us:
A leading global manufacturer, marketer and distributor of animal health products and veterinary pharmaceuticals
Why join us?
We have a caring, family culture which ensures employees feel supported in their personal and professional lives. We work through challenges together and provide a working environment where people feel valued and where they can learn and grow within our business.
Job Details
provides leadership and direction to drive manufacturing operations and suppliers towards higher quality products and processes in accordance with corporate strategy, cGMP, and regulatory compliance. This includes developing strategic business plans and the tactical actions and resources necessary to execute them. The Director will be responsible for managing operational budgets including leading continuous improvement initiatives in quality. This position manages the performance of 3 direct reports; Quality Assurance Supervisor, Quality Compliance Supervisor and Sr. Quality Control Manager
Essential:
Desirable:
- Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
- Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes (Continuous Improvement) and supporting new product development.
- Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance.
- Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
- Monitors QA systems and advises executive team on system performance; publishes statistics regarding performance against set goals and makes recommendations.
- Leads the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
- Acts as the primary contact with regulatory agencies for all communication for the site.
- Leads by example and proactively communicates and collaborates with internal staff, colleagues, the union and external stakeholders to drive results.
- Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
- Responsible for ensuring that all product quality complaints are being adequately investigated, trended, & reported and collaborates with department to ensure full customer satisfaction.
- Responsible for final product release to customer.
- Acts as a liaison with customer auditors and ensures corrective actions are completed according to customer specifications.
- Participates as required in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Approves/rejects as required.
- Organizes and hosts facility audits by customers, FDA and Health Canada including responding to corrective actions and /or observations as required.
Essential:
- Ten years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, with 5 years in a leadership role
- BSc degree in science or related field
- Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes
- Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
Desirable:
- MS degree or MBA as asset
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.