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:

• B.A. or B.S. degree required, preferably in appropriate Science, IT, Engineering or Business discipline.

Required:   

• Minimum 4 years of experience in Pharmaceutical or related industry.

• Excellent attention to detail.

• Strong leadership and collaboration skills.

• Excellent verbal and written communication and presentation skills

• Ability to independently manage multiple priorities and projects.

Preferred:   

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

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

• Extensive knowledge of GMP, GLP and/or GCP regulations

• Experience participating in US and EU health authority inspections.

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

• Active Pharmaceutical Ingredient experience and knowledge of ICH Q7

• Quality Risk Management

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

• 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:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: