Sokol Materials & Services
CQV Associate Director
Sokol Materials & Services, Skillman, New Jersey, us, 08558
CQV Associate Director
Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1)
Job Type
Lead
Workspace
On-site position (no remote or hybrid options)
Target Hiring Date
January 2025
Salary
$120,000 - $150,000 Per Year
Work Authorization
Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.
Requirements
Education and Experience:
Bachelor’s degree in engineering, life sciences, or related field; Master’s degree preferred.
Professional certifications in CQV, Project Management (PMP), or Quality Management are advantageous.
10+ years of CQV experience in relevant industries, including 5+ years in leadership.
Expertise across disciplines such as Automation, Computer System Validation, Contamination Control, Clean Utilities, and Manufacturing Equipment.
Familiarity with digital CQV tools (e.g., Kneat, VEEVA) is beneficial.
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
About the Role
As the Associate Director, CQV at Sokol GxP Services, you will oversee CQV strategy development and execution, manage client relationships, and ensure regulatory compliance. Serving as a CQV Subject Matter Expert (SME), you will provide industry-recognized expertise, support client project teams, and foster knowledge-sharing within the organization. This position demands strategic insight, specialized skills, and the ability to drive business growth and deliver successful project outcomes.
Supervisory Responsibilities: None.
DUTIES / RESPONSIBILITIES
________ Knowledge, Skills & Abilities ________
Expert in CQV principles, risk-based validation, and regulatory standards (FDA, EMA, GMP).
Strong team leadership and project oversight, ensuring on-time, quality delivery across complex CQV projects.
Skilled in client relationship building, identifying new opportunities, and enhancing industry presence.
Advanced in technical documentation, with clear and effective communication skills across all levels.
Critical thinker focused on problem-solving and driving operational efficiency.
Competent in overseeing vendor quality and integrating sustainable practices to reduce environmental impact.
________ Key Responsibilities ________
Lead a team of CQV Project Managers, engineers, and contractors.
Guide clients, senior management, and project teams as an SME across multiple disciplines.
Direct internal CQV strategies, policies, and procedures.
Engage in industry events, contribute articles, and build a robust professional network.
Represent Sokol CQV with professionalism in all client engagements.
Oversee CQV project planning, execution, and documentation, ensuring quality and adherence to timelines and budgets.
Work with the Business Development team to attract new clients and enhance existing client relationships.
Lead training, proposal development, and mentor team members.
Maintain compliance with regulatory requirements (e.g., FDA, EMA).
Support internal and external audits, inspections, and regulatory submissions.
Manage the CQV budget, resource allocation, and expenses.
Mentor team members, promote collaboration, and provide skill development opportunities.
Select and manage vendors, ensure quality, and oversee performance.
Integrate sustainable practices into CQV operations and promote social responsibility.
Enhance CQV processes through continuous improvement and best practices.
About the Company
Join Sokol GxP Services – Where Innovation Meets Integrity!
Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation, offering competitive health benefits, PTO, holiday pay, volunteer hours, a relocation budget*, a 401K** program, and professional development opportunities. Plus, take advantage of our Employee Referral program! Be part of a dynamic team with fantastic opportunities for growth and professional development!
Let’s shape the future of life sciences together!
All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.
Equal Opportunity Employer Statement:
Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
*Relocation support will be determined on a case-by-case basis.
**Our 401K program is set to launch in the 2025 fiscal year.
By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.
Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1)
Job Type
Lead
Workspace
On-site position (no remote or hybrid options)
Target Hiring Date
January 2025
Salary
$120,000 - $150,000 Per Year
Work Authorization
Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.
Requirements
Education and Experience:
Bachelor’s degree in engineering, life sciences, or related field; Master’s degree preferred.
Professional certifications in CQV, Project Management (PMP), or Quality Management are advantageous.
10+ years of CQV experience in relevant industries, including 5+ years in leadership.
Expertise across disciplines such as Automation, Computer System Validation, Contamination Control, Clean Utilities, and Manufacturing Equipment.
Familiarity with digital CQV tools (e.g., Kneat, VEEVA) is beneficial.
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
About the Role
As the Associate Director, CQV at Sokol GxP Services, you will oversee CQV strategy development and execution, manage client relationships, and ensure regulatory compliance. Serving as a CQV Subject Matter Expert (SME), you will provide industry-recognized expertise, support client project teams, and foster knowledge-sharing within the organization. This position demands strategic insight, specialized skills, and the ability to drive business growth and deliver successful project outcomes.
Supervisory Responsibilities: None.
DUTIES / RESPONSIBILITIES
________ Knowledge, Skills & Abilities ________
Expert in CQV principles, risk-based validation, and regulatory standards (FDA, EMA, GMP).
Strong team leadership and project oversight, ensuring on-time, quality delivery across complex CQV projects.
Skilled in client relationship building, identifying new opportunities, and enhancing industry presence.
Advanced in technical documentation, with clear and effective communication skills across all levels.
Critical thinker focused on problem-solving and driving operational efficiency.
Competent in overseeing vendor quality and integrating sustainable practices to reduce environmental impact.
________ Key Responsibilities ________
Lead a team of CQV Project Managers, engineers, and contractors.
Guide clients, senior management, and project teams as an SME across multiple disciplines.
Direct internal CQV strategies, policies, and procedures.
Engage in industry events, contribute articles, and build a robust professional network.
Represent Sokol CQV with professionalism in all client engagements.
Oversee CQV project planning, execution, and documentation, ensuring quality and adherence to timelines and budgets.
Work with the Business Development team to attract new clients and enhance existing client relationships.
Lead training, proposal development, and mentor team members.
Maintain compliance with regulatory requirements (e.g., FDA, EMA).
Support internal and external audits, inspections, and regulatory submissions.
Manage the CQV budget, resource allocation, and expenses.
Mentor team members, promote collaboration, and provide skill development opportunities.
Select and manage vendors, ensure quality, and oversee performance.
Integrate sustainable practices into CQV operations and promote social responsibility.
Enhance CQV processes through continuous improvement and best practices.
About the Company
Join Sokol GxP Services – Where Innovation Meets Integrity!
Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation, offering competitive health benefits, PTO, holiday pay, volunteer hours, a relocation budget*, a 401K** program, and professional development opportunities. Plus, take advantage of our Employee Referral program! Be part of a dynamic team with fantastic opportunities for growth and professional development!
Let’s shape the future of life sciences together!
All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.
Equal Opportunity Employer Statement:
Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
*Relocation support will be determined on a case-by-case basis.
**Our 401K program is set to launch in the 2025 fiscal year.
By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.