Site Quality Head Carlsbad
Site Quality Head Carlsbad
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$ 138600 - 257400
1 Vacancy
Job Description
Band
Level 5Job Description Summary
At Advanced Accelerator Applications a Novartis company we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with experience building teams in startup environments to lead the Quality function at our new Carlsbad site.As the Site Quality Head you will provide quality assurance oversight and be accountable for supporting site start up and Quality operations at the Carlsbad site. You will provide technical and strategic leadership for the Manufacturing site for all qualityrelated matters and be part of the Site Senior Leadership Team.
Job Description
Key Responsibilities:
- Support plant start up expansions and product transfers. Create and maintain updated project plans to track progress and support in informing senior management. Ensure proper preparation and consolidation of the budget for the Quality Unit.
- Provide leadership for strategic site initiatives and represent site SLT quality in local crossfunctional and global projects teams as team member or team leader that represent site quality. Establish Quality as a valued business partner.
- Provide leadership direction and support to the people within the Quality Assurance department and ensure that they are qualified achieve a high level of competence are motivated and carry out their duties in a safe manner.
- Work with internal and external personnel to create user requirements and specifications to be used for projects in compliance with company standards for equipment process and facilities.
- Ensure all facilities utilities and equipment are designed and installed to be operated in a safe and effective manner and are compliant with applicable standards
- Ensure that during project phase planning construction commissioning qualification (IQ OQ and PQ) including any other validation activity complies with cGMP
- Timely escalation of risks in meeting timelines and / or budget incorporating site master planning and the longterm strategic plan.
- Ensure adequate management of product critical quality issues (deviations out of specifications). Ensure investigations are correctly executed and adequate CAPAs are defined and proper follow up of CAPAs effectiveness. Review provide guidance for escalate where appropriate and approve Health Authority notifications.
- Define implement monitor consolidate and analyze Site Quality KPIs. Ensure Site Quality Committee is established ensure relevant corrective and preventive actions are endorsed and implemented.
- Drive for Site management team accountability. Coordinate the generation and monitor the of the Site Quality Plans DI Plan Site Quality Risk Assessments and other relevant gap assessments.
Essential Requirements:
- BS in Life Sciences and/or related experience in lieu of degree. 10 years of experience in GMP Pharmaceutical Manufacturing (including laboratory operations and Aseptic experience) at least 3 years combined of relevant experience in Quality Control and/or Quality Assurance.
- Proven track record and practical experience in supporting a Quality Control operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections from major Health Authorities (e.g. US FDA EMA)
- Indepth knowledge of cGMP FDA regulations 21 CFR Parts 211 212 and ICH regulations. Understanding of United States Pharmacopoeia (USP) European Pharmacopoeia (EP) American Chemical Society (ACS).
- Proven ability to manage multiple projects with moderate resource requirements risk and/or complexity. Highly developed management and communication skills with experience in working in a matrix organization.
- Experience in process improvement approaches (Lean Six Sigma Total Quality Management 5S etc. Understands economic business impacts of decisions. Defining and implementing productivity improvement measures.
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The pay range for this position at commencement of employment is expected to be between $ 138000 and $ 257400 per year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Audit Management Communication Skills Continued Learning Dealing With Ambiguity Decision Making Skills Employee Performance Evaluations Gmp Procedures Inspection Readiness Organizational Skills People Management People Management and Leadership Product Release Qa (Quality Assurance) SelfAwareness Technological ExpertiseEmployment Type
Full-Time
