Manager Quality CQV

Siegfried; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance, Short & Long Term DI

Pet Insurance

Generous PTO, Sick & Holiday Time Off

401K

Job summary

Siegfried in Irvine, CA seeks a senior CQV leader to oversee commissioning, qualification and validation for drug products, devices, and manufacturing processes. You will own the site validation strategy and manage master plans, protocols and reports, coordinating cross-functional teams and external consultants.

Ideal candidates have 6–10 years in FDA/GMP environments, aseptic manufacturing experience, and strong leadership.

Qualifications

• Experience with commissioning, qualification, and validation activities within Site Validation Master Plan.
• Ability to delegate responsibilities and coordinate across functional areas.
• Strong analytical, communication, and technical writing skills; GMP documentation experience.
• Experience in GMP environments; aseptic manufacturing preferred.

Responsibilities

• Own and manage the site validation strategy, rationale, and approach.
• Oversee Site Validation Master Plan activities and approve qualification documents.
• Coordinate validation life cycle for existing and new products and projects.
• Lead QA Sterilization Validation and manage consultants as needed.
• Support regulatory inspections and client audits related to CQV.

Skills

CQV expertise

GMP compliance

Leadership

Project coordination

Regulatory inspections

Education

Bachelor's degree in engineering/science

Tools

Validation software suites

Job description

Expect to grow, personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you\'ll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

Your Role

Responsible for oversight and management of all commissioning, qualification, and validation (CQV) processes for new and existing drug products, medical devices, and manufacturing processes at Siegfried Irvine.

Your Profile

Responsibilities

• Ownership and management of the overall site validation strategy, rationale, and approach.
• Management of all activities within the scope of the Site Validation master Plan and maintenance of the Site Validation Master Plan, including oversight and approval of qualification activities and documents, including approval of qualification protocols, within the scope of the subordinate validation processes:
  • Facility, Utility, and Equipment Commissioning and Qualification
  • Sterilization Validation
  • Aseptic Process Simulation/Media Fill Validation
  • Manufacturing Process Validation/PPQ Validation
  • Cleaning Validation
  • Analytical Method Validation
  • Computer System Validation
  • Environmental Monitoring Program
• Coordination, management, and oversight of the process validation life cycle process for existing products and for new product introduction projects.
• Coordination of schedule, resources, activities, and deliverable requirements with Project Management, Engineering, MS&T, and Operations for the design, delivery, commissioning, and qualification of facility, utility, and equipment systems as part of new product introductions.
• Coordination of schedule, resources, activities, and deliverable requirements with MS&T and Operations for continued process verification of existing, validated processes.
• Oversight and management of the QA Sterilization Validation group.
• Oversight and management of validation consultants and contractors, where applicable, in support of activities within the scope of the Site Validation Master Plan.
• Ownership, management, and oversight of site GMP training and championing of site GMP culture, including implementation of science-based and risk-based principles, approaches, and decision-making for site CQV processes.
• Participation in change management, deviations, root cause investigations, and other impact assessments to determine impact to and corrective/preventive actions for qualified systems and validated processes.
• Representation of the site CQV program as part of regulatory inspections, client audits, and related activities.

Required Knowledge, Skills And Abilities

Experience with the commissioning, qualification, and validation activities and processes within the scope of the Site Validation Master Plan.

• Ability to delegate responsibilities and to coordinate activities and responsibilities with other functional areas
• Ability to manage direct reports and to coordinate and manage cross-functional teams
• Ability to analyze and interpret validation test data to determine if processes or systems have met acceptance criteria
• Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
• Leadership Skills: Proven ability to influence others and lead significant change.
• Strong communication skills both written and verbal, including technical writing
• Ability to work on multiple projects simultaneously.
• Proven experience of managing compliance to GMP regulations and guidance. Current working knowledge of cGMPs and an understanding of cleanroom manufacturing environments and related equipment.
• Ability to work consistently and compliantly, following standard operating procedures and quality policies.
• Able to review and approve GMP documentation to a high standard and relating to validation including SOPs, protocols, and reports.

Required Education And Experience

• Bachelor\'s Degree (BA or BS) in engineering, science, or other, related technical discipline
• 6 – 10 years of experience in an FDA or other GMP-regulated environment required
• 6 – 10 years of experience working in the pharmaceutical industry preferred
• 3 – 5 years of supervisory experience managing direct reports and/or managing teams of 5 – 10 people preferred
• Experience working in aseptic manufacturing/cleanrooms preferred

Target Salary Range: $125,000 - 135,000

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Your Benefits

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• Generous PTO, Sick & Holiday Time Off
• 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.