Manager, Quality Engineering (Change Control)

ZipRecruiter; Verona; In loco; USD 100.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company is seeking a Manager for Quality Engineering Change Control in Verona. You'll oversee the Change Control system, ensuring quality oversight and collaboration across teams. This pivotal role requires expertise in GMP regulations and a proven track record in pharmaceuticals.

Competenze

• At least 5 years of experience in a pharmaceutical/biotech or CRO setting.
• Knowledge of GMP, GLP, FDA, EU, and ICH regulations.
• Leadership experience in projects or teams.

Mansioni

• Collaborate across functions to assess change controls and communicate changes.
• Monitor and report on change progress to meet timelines.
• Act as process owner for change control within the Arrowhead QMS.

Conoscenze

Excellent communication

Problem-solving skills

Detail-oriented

Team player

Formazione

Bachelor's degree in a relevant science field

Quality certifications like CQA or CQMP

Strumenti

Microsoft Word

Excel

Descrizione del lavoro

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical-stage biopharmaceutical company that develops medicines to treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient delivery modes, Arrowhead therapies trigger RNA interference to induce rapid, deep, and durable gene knockdown. RNA interference, or RNAi, is a natural mechanism in cells that inhibits specific gene expression, affecting protein production. Arrowhead's RNAi-based therapeutics leverage this pathway to address various diseases.

Our focus is on developing innovative drugs for genetically based diseases, often characterized by overproduction of certain proteins. Our versatile RNAi technologies enable us to target conditions across many therapeutic areas, including those not addressable by small molecules or biologics. We are leading in applying RNAi beyond the liver, with clinical pipelines targeting liver and lung diseases, alongside promising preclinical candidates.

Headquartered in Pasadena, CA, with R&D in Madison, WI, and San Diego, CA, our team comprises nimble, science-driven innovators committed to bringing new therapies to patients.

The Position

The Manager, Quality Engineering Change Control, will serve as a Subject Matter Expert within the cGMP-regulated Quality organization. This role oversees the Change Control system and Effectiveness Checks, providing quality oversight for equipment, instruments, computerized systems, processes, analytical methods, vendor changes, and regulatory documentation. The incumbent will collaborate with cross-functional teams to assess proposed changes, determine impacts, and ensure proper implementation, managing change completion timelines.

Responsibilities

• Collaborate across functions to assess change controls, impact, define actions, and track completion.
• Communicate changes to stakeholders for proper implementation.
• Monitor and report on change progress to meet timelines and regulatory commitments.
• Coordinate evaluation of Supplier Notices of Change.
• Provide training on change control processes.
• Act as the process owner for change control in the Arrowhead QMS.
• Evaluate proposed changes to computerized systems.
• Support audit activities related to change control.
• Contribute to continuous improvement and CAPA efforts.
• Assist in and approve change assessments.
• Provide final approval for change controls and effectiveness checks.
• Summarize change controls for annual reviews.
• Maintain and update procedural documents as needed.

Requirements

• Bachelor's degree in a relevant science field.
• Quality certifications like CQA or CQMP are desirable.
• At least 5 years of experience in a pharmaceutical/biotech or CRO setting, with responsibilities related to equipment/instrument qualification.
• Knowledge of GMP, GLP, FDA, EU, and ICH regulations.
• Excellent communication skills and ability to work with diverse professionals.
• Motivated team player eager to contribute and grow.
• Detail-oriented self-starter with problem-solving skills.
• Leadership experience in projects or teams.
• Proficiency in Microsoft Word and Excel.
• Experience with electronic document management systems in regulated environments.

Wage range in Wisconsin: $100,000—$120,000 USD. Arrowhead offers competitive salaries and benefits. Applicants must have US work authorization.

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