Senior Specialist, Quality Assurance - Internal Auditing (Hybrid)

Job Description

This Senior Specialist position reports to the Rahway Site Compliance Lead in Global Development Quality and is responsible for leading and supporting activities that include, but are not limited to internal audits, GMP readiness, Health Authority inspections and general compliance initiatives.

Responsibilities include, but are not limited to:

• Independently leads and supports comprehensive internal audits of GMP facilities or systems supporting clinical supplies manufacture, testing, storage, and distribution to ensure compliance to applicable regulations, policies, and procedures. 

• Issues report summarizing findings and tracks resulting CAPAs to satisfactory closure in order to maintain appropriate risk posture for the site. 

• Maintains an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations.

• Provides support for the preparation and execution Health Authority Inspections. 

• Proactively identifies, develops and implements opportunities for work/process improvement and efficiency. 

• Represents Global Development Quality on cross-functional teams, ensuring the flow of information and providing Quality guidance.

• Develops and maintains metrics and key performance indicators to measure trends and improve quality performance. Presents outcomes to management and governing Quality Councils.

• Leads and supports GMP readiness activities for new manufacturing facilities, laboratories and support areas.

• Promotes a culture of quality and operational excellence.

• Proactively identifies areas for improvement and work across multiple organizations to influence and implement solutions.

Education:

• Required: Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), IT or Engineering discipline  

• Preferred: Advanced degree

Required:   

• Minimum 5 years of experience in Pharmaceutical or related industry

• Experience leading internal or external Good Manufacturing Practice (GMP) audits

• Extensive knowledge of FDA and EU GMP regulations as well as ICH guidelines

• Excellent attention to detail

• Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering

• Experience participating in US and EU health authority inspections.

• Strong leadership and collaboration skills

• Excellent verbal and written communication and presentation skills

• Proficiency with digital tools and computer applications; knowledge and competency in PowerPoint, Excel, and Word

• Ability to independently manage multiple priorities and projects

Preferred:   

• Familiarity with R&D or clinical supply areas and processes

• Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines.

• Active Pharmaceutical Ingredient experience and knowledge of ICH Q7

• Quality Risk Management

• Experience using AI tools and applications

• Experience with industry standard computer applications (e.g., Delta-V and/or PAS-X, SAP, laboratory notebooks, Veeva, LIMS, Empower)

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other