The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are seeking a qualified Associate Director, Head of Quality Control who will be responsible for all aspects of the Quality Control organization, As part of a dynamic Contract Manufacturing Organization, the successful candidate will work with internal and external stakeholders to manage complex timelines, meet customer deliverables and develop a best-in-class Quality Control organization. This position will oversee the teams performing Environmental Monitoring and sampling, inspection and testing of in-process samples, utilities and raw materials, as well as have oversight of contract laboratories performing testing.
As Head of Quality Control, you will develop and drive appropriate performance KPIs, manage internal and external timelines and working with various stakeholders to successfully deliver results that meet customer expectations as well as conform to regulatory requirements. This role is responsible for developing a comprehensive Quality Control program and strategy meets current compliance requirements as well as ensuring all of the activities within the team follow established SOPs and regulations to support that strategy.
Who are you:
MA/MS or Ph.D in scientific discipline with 8 or more years of relevant experience
BA/BS in scientific discipline with 10 or more years of relevant experience
Minimum of eight (8) years of leadership/supervisory experience.
Minimum of eight (8)years of experience in cGMP Quality Control or Assurance environment. CMO Experience is a plus.
Experience in Environmental Monitoring, Utility and Raw Material Testing and Disposition, Quality Systems, and Regulatory Inspections
Strong Foundation in quality systems supporting ISO 9001 certification as well as FDA and EU regulations
Expert knowledge of governmental regulatory guidelines relating to the testing and manufacturing of biologics and pharmaceuticals
Experience with Lean Manufacturing and Continuous Improvement concepts
Leads, manages and develops Quality Control team to support the daily operations of the Carlsbad Site
Ensure that Quality metrics are met, that performance is continually improving, and that metrics are communicated accurately to enable data-based decision making.
Performs analysis and interpretation of data in support of events and CAPAs.
Develop strong working relationships with internal clients and external Contract Laboratory representatives.
Review/Approve Qualification protocols and reports.
Support/ participate in new product transfers
Ensures adherence to the Product Development Process (PDP)
Liaise with appropriate cross-functional departmental areas to determine root cause for non-conformances
Create/Revise/Approve SOPs and other GMP documentation
Maintain high level knowledge of lab procedures and assays.
Contributes ideas and suggestions to improve Quality systems, Compliance and Safety
Leads internal and external interactions such as teleconferences with clients and contract laboratories
Responsible for employee coaching and development, determining employee responsibilities, evaluating and managing performance as appropriate.
Identify, recruits, and retain top-notch talent.
Promote a culture of continuous improvement within Quality; act as champion on initiatives to drive
Comply with company EH&S requirements. Promote a safety-first culture.
Performs other duties as assigned
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties, the employee is:
Constantly required to sit and reach to use computers and other office/lab equipment
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Employee frequently works in a professional office environment and production areas with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off- shift, weekend, and overtime duties may be required as assigned by the manager of the employee.
Job Requisition ID: 205500
Career Level: E - Professional (10+ years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
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