Quality Manager

Quality Manager

- LOCATION: Swiftwater PA Hybrid

- DURATION: 12 Month

- Visa: SUBMIT WITH the following, or the email will immediately be deleted, Thank you;

- Photo ID with Month & Day of Birth

- Valid LinkedIn profile, ( Any professional in today's day & age should have one !)

- (2-3) references from past managers with their COMPANY EMAIL, not personal addresses.

- Candidates MUST be prescreened

• 6 9 years of experience in the pharmaceutical or biopharmaceutical industry (related manufacturing environments also considered).
• Proven track record in Computerized System Validation (CSV).
• Hands-on experience with MES and ERP (SAP) systems.
• Demonstrated experience working within FDA-regulated environments.

Position Overview

We are seeking a highly skilled Quality Manager III with a strong engineering background to join our Quality Validation team. This role is pivotal in ensuring the integrity of computerized systems and equipment within a high-stakes biopharmaceutical manufacturing environment. The ideal candidate will bridge the gap between technical engineering requirements and rigorous regulatory compliance, specifically focusing on computerized system validation (CSV) and equipment qualification.

Key Responsibilities

• Validation & Qualification: Lead and execute computerized system validation (CSV) and computerized equipment qualification projects to ensure compliance with global regulatory standards.
• CAPA Leadership: Direct and manage Corrective and Preventive Action (CAPA) activities, ensuring thorough root cause analysis and timely implementation of effective solutions.
• Cross-Functional Collaboration: Serve as the primary quality interface for engineering and manufacturing teams, fostering a culture of compliance while maintaining operational efficiency.
• Project Management: Simultaneously manage multiple high-priority projects, ensuring all deliverables meet strict deadlines without compromising quality.
• Regulatory Compliance: Apply deep working knowledge of Quality System Regulations (QSR) and FDA requirements to daily operations and long-term validation strategies.

Qualifications & Requirements

Education:

• Required: Bachelor's or Undergraduate Degree in Engineering, Life Sciences, or a related technical discipline.
• Preferred: Master's Degree

Experience:

• 6 9 years of experience in the pharmaceutical or biopharmaceutical industry (related manufacturing environments also considered).
• Proven track record in Computerized System Validation (CSV).
• Hands-on experience with MES and ERP (SAP) systems.
• Demonstrated experience working within FDA-regulated environments.

Skills:

• Technical Proficiency: Strong working knowledge of Quality System Regulations and computerized equipment qualification.
• Communication: Exceptional verbal and written communication skills, capable of translating complex technical data for diverse stakeholders.
• Organization: Highly detail-oriented with the ability to navigate complex documentation and strict timelines.
• Software: Proficiency in Microsoft Office Suite (Excel, Word, Outlook).

Nice to have:

• Strong Microsoft (Excel, Word, Outlook) skills.
• Work environment: Office setting, team of 4, free parking.
• Interview process: Zoom or possibly in person

Work Environment

• Located on-site in Swiftwater, PA, within a collaborative team of quality professionals.
• Fast-paced, deadline-driven manufacturing setting requiring high adaptability.

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom