Site Qc Head (Associate Director)

10+ years

$151,200–$226,800 Annually

Remote, USA

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here’s a rewritten and streamlined version of the job summary for clarity and readability:

Quality Control Leader – Site QC Head
Location: Millburn, New Jersey, USA

About Advanced Accelerator Applications:
At Advanced Accelerator Applications (a Novartis company), we are driving innovation in nuclear medicine, delivering next-generation targeted radioligand therapies for cancer patients. We are seeking an experienced Quality Control Leader to oversee the Millburn site’s Quality Control (QC) organization and support our mission to achieve ambitious goals.

About the Role:
As the Site QC Head, you will lead a team of approximately 40 associates, managing QC functions including release and in-process testing, environmental monitoring, sterility assurance, stability testing, and analytical science and technology. Reporting to the Millburn Site Quality Head, you will ensure compliance with all applicable regulatory requirements while fostering a culture of quality excellence.

Key Responsibilities:

Lead the QC organization, managing resources to meet timelines and milestones.
Develop and strengthen a quality-focused culture within the QC team, with robust training and growth plans for associates.
Establish and monitor departmental objectives and KPIs (e.g., cycle time, reliability, RFT).
Ensure quality systems for QC, Environmental Monitoring, Stability, and Analytical Science meet regulatory requirements.
Lead inspection readiness efforts and represent QC during internal and external audits.
Drive validation, transfer, and investigation activities (e.g., deviations, OOS, OOE, OOT, CAPAs).
Ensure QC lab equipment and methods are qualified and validated for intended use.
Manage QC-related support for site product launches and budget planning.
Stay informed on emerging regulatory trends and collaborate with external partners and working groups.

Essential Requirements:

Education: BSc in Chemistry, Biology, Pharmacy, Biotechnology, Biomedical Engineering, or related field (Advanced degree preferred).
Experience:
- 10+ years in QC, QA, Quality Systems, or Regulatory Compliance in the pharmaceutical, diagnostics, or medical device industries.
- Prior experience in aseptic manufacturing; experience in advanced therapies (e.g., Radioligand Therapy) preferred.
- 5+ years of leadership experience, including talent management and team development.
Expertise: Working knowledge of FDA and international regulatory requirements, industry quality standards, and cGMP guidelines.
Skills: Experience in Health Authority inspections, microbiology, environmental monitoring, and sterility assurance.

Desirable Requirements:

Experience in global, matrix organizations.
Familiarity with process improvement methodologies such as Lean, Six Sigma, or 5S.

Compensation and Benefits:

Pay range: $151,200–$226,800/year (subject to adjustments based on market and experience).
Comprehensive benefits package, including medical, financial, paid time off, 401(k), and more.
Explore our Novartis Life Handbook for full details.

Commitment to Diversity & Inclusion:
We celebrate individuality and are committed to building an inclusive, equitable workplace reflective of the communities we serve.

Accessibility and Accommodation:
Novartis provides reasonable accommodations for individuals with disabilities. For support, contact: us.reasonableaccommodations@novartis.com or call +1 (877) 395-2339.

Join Us:
Be part of a team reimagining medicine to improve lives. Learn more about Novartis and connect with our Talent Network.

Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Employment Type: Full-Time, Regular

Let me know if you’d like further adjustments!

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Site Qc Head (Associate Director)

Job Description

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