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Your Role:
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 Head of Quality who will be responsible for all aspects of the Quality 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 organization. This position will oversee the teams responsible for Quality Systems Management, Quality Control, and Quality Assurance oversight of all aspects of GMP manufacturing.
As Head of Quality, you will manage and develop the Quality group to further mature a culture of compliance excellence and continuous improvement. You will develop and drive appropriate performance KPIs, manage internal and external timelines and work with stakeholders to successfully deliver results that meet customer expectations as well as conform to regulatory requirements. This role is responsible for managing our Quality Systems to meet evolving compliance requirements as well as ensuring all the activities within the team to support that objective.
Requirements:
Lead, manage, and develop the Quality group (QA and QC)Instill a culture of continuous improvementPlay a key role on the leadership team advocating for Quality and driving Quality cultureEnsure that direct reports and their teams carry out their duties according to the principles of GMPParticipate in continuous improvement projects and present metrics to senior managementMaintain ‘audit ready’ status at all times and coordinate site activities in preparation for regulatory auditsParticipate in responses/corrective actions to regulatory and other audit findingsManage and support the systems required to perform the core site activities of the Quality Management System, including deviations, Out of Specifications, Corrective and Preventative Actions, investigations, change control, validations, material disposition, complaints, internal and external audit/inspections, and customer enquiriesLead QC teams, ensuring microbial control of the facility and efficient testing processesPerform gap assessments and lead the site implementation of corporate Quality policiesProvide oversight to the review and approval of GxP documents, including protocols, Technical specifications, batch records, workbooks, SOPs, validation protocols, and all other QMS documentationReview and approve executed GXP documents and recordsParticipate in the recruitment and development of teams using available tools and proceduresActively promote and demonstrate adherence to Health and Safety policies and practices, acting as a role model for other employees within the organization
Who You Are
Minimum Qualifications:
Experienced pharmaceutical professional with roles in Quality Assurance and other operational areasSomeone with firsthand experience with regulatory inspections and the regulatory approval pathwayMA/MS or PhD in scientific discipline with 8+ years experience or BA/BS with 12+ years of relevant experienceOrganized and detailed oriented with strong and effective written, verbal, mathematical, and interpersonal communication skills.Intermediate/advanced knowledge of MS Office
Preferred Qualifications:
Bachelors degree in a scientific discipline (or relevant professional experience)Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticalsContract Manufactured Organization (CMO) experience Ability to work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.Ability to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity.
Additional Local Needs:
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 equipmentConstantly required to view objects at close and distant rangesFrequently required to communicate with others
Employee frequently works in a professional office environment with computer equipment and at times within a manufacturing and laboratory environment with 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.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html