Sokol Materials & Services
Associate Director CQV
Sokol Materials & Services, Skillman, New Jersey, us, 08558
Associate Director CQV
Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1)
Job Type
Senior
Workspace
Hybrid
About the Role
This role involves overseeing the development and execution of CQV strategies, managing client relationships, and ensuring compliance with regulatory requirements. The Associate Director CQV engages in strategic initiatives, provides specialized expertise, and supports client project teams. As a CQV Subject Matter Expert (SME), they play a crucial role in internal knowledge sharing, proposal development, and training content creation. The ideal candidate is recognized within the industry for their expertise, thought leadership, and robust network. The Associate Director CQV should be able to drive business growth and lead successful project delivery.
Responsibilities:
Leadership & Strategy:
Lead and manage a team of CQV Project Managers (PMs), engineers, and contractors to ensure high performance and effective resource allocation.
Act as the SME in multiple disciplines and provide guidance to clients, internal senior management, and project teams.
Develop and implement internal CQV strategies, policies, and procedures.
Stay updated on industry trends, best practices, and regulatory changes, and incorporate them into SOKOL's CQV strategies.
Actively engage in industry forums, speak at conferences, and contribute articles to establish thought leadership in CQV, wherever possible.
Build and maintain a robust network of industry contacts to enhance SOKOL's recognition as a CQV expert.
Project Oversight & Client Relationship Management:
Serve as the primary SOKOL CQV representative, embodying the company's values and expertise in all client interactions to ensure positive, professional, and productive engagements.
Oversee the planning, execution, and documentation of SOKOL’s CQV projects, ensuring timelines, budgets, and quality standards are met.
Collaborate with PMs and other stakeholders to integrate CQV activities into overall project plans.
Be prepared to take on the PM role as necessary.
Offer consulting services to clients, delivering top-tier CQV solutions tailored to their specific needs.
Participate in strategic projects that pave the way for larger team engagements or provide specialized expertise within broader initiatives.
Provide expert guidance and oversight to client project teams during project initiation and implementation.
Business Development:
Collaborate with Business Development team to Identify and pursue new business opportunities by researching organizations and individuals.
Enhance the value of existing client relationships through exceptional service delivery, while attracting new clients through industry engagement and networking.
Internal Support & Knowledge Transfer:
Serve as an internal resource for CQV expertise, supporting proposal development, internal qualifications, and training programs.
Mentor and develop team members, creating and delivering upskill training content to enhance organizational capabilities.
Draft and review high-quality, consistent CQV estimates and proposals.
Regulatory Compliance & Quality Assurance:
Ensure that all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA, etc.) as well as the internal and client's GMP standards.
Oversee and participate in the development, review, and approval of CQV documentation.
Support both internal and external audits, inspections, and regulatory submissions related to CQV.
Implement continuous improvement initiatives to enhance the efficiency and effectiveness of CQV processes.
Budgeting & Resource Management:
Develop and manage the CQV budget, ensuring cost-effective use of resources.
Monitor project expenses and ensure they align with financial goals.
Manage the purchase, maintenance, and calibration of test equipment.
Team Development:
Mentor and develop CQV team members, fostering a culture of learning, innovation, and excellence.
Identify training needs and provide opportunities for skill development within the CQV team.
Promote cross-functional collaboration and knowledge sharing across the organization.
Vendor & Contractor Management:
Manage relationships with external CQV service providers, ensuring that deliverables meet SOKOL standards and regulatory requirements.
Evaluate and select vendors, negotiate contracts, and monitor performance throughout project lifecycles.
Social and Environmental Performance:
Incorporate sustainability practices into the CQV process, including energy efficiency, waste reduction, and resource conservation.
Evaluate the environmental impact of CQV activities and implement strategies to minimize carbon footprint and waste generation.
Engage with project teams to promote social responsibility, ensuring that projects contribute positively to the communities in which they operate.
Support initiatives that align with Sokol GxP Services’ commitment to social equity, including workforce diversity and local community engagement.
Continuous Improvement:
Promote continuous improvement initiatives within CQV processes.
Implement best practices and innovative solutions to enhance efficiency and quality.
Evaluate project outcomes and apply lessons learned to future projects.
Working Conditions*
*The role may require occasional travel to project sites and vendor locations.
*The role may involve working in cleanroom environments and adhering to strict safety and quality protocols.
Salary range:
$120,000 - $150,000 per year
Benefits:
PTO
Health Insurance
Paid Holidays
Relocation Bonus
Company Laptop
Work Authorization:
Applicants must have the legal right to work in the United States without needing sponsorship.
Target Hiring Date
Immediately
Salary
$120,000 - $150,000 Per Year
Requirements
A minimum of a Bachelor's degree in engineering, life sciences, or a related field is required. A Master’s degree is preferred.
Professional certifications in CQV, Engineering, Project Management (PMP), or Quality Management (e.g., ASQ) are advantageous.
At least 10 years of experience in CQV roles in the pharmaceutical, biotechnology, cell therapy, medical device, or life sciences industry is required, with at least 5 years in a leadership position.
SME knowledge in multiple disciplines such as: Automation, Computer System Validation, Contamination Control, Clean Utilities, CTU, Facility, Manufacturing Equipment, Packaging Equipment, Sterilization, etc.
In-depth knowledge of regulatory requirements (FDA, EMA, ICH, ISO, etc.) and GMP standards is necessary.
Proven experience in managing complex CQV projects from concept to completion is essential.
Strong leadership, communication, and interpersonal skills are required.
Candidate must be able to manage multiple priorities in a fast-paced environment.
Experience with risk-based validation approaches and continuous improvement methodologies is expected.
Experience with digitalization of CQV processes and tools (e.g., electronic validation management systems such as Kneat, VEEVA, Valgenesis, etc.) would be beneficial.
About the Company
SOKOL GxP Services is a growing Commissioning Qualification Validation (CQV) and GMP service provider for pharmaceutical, biotechnology, cell therapy and medical device companies. Our primary goal is to help our clients achieve regulatory compliance and ensure the quality and safety of their products. We have a team of experienced professionals that offers comprehensive CQV services, including equipment, utilities, and facility commissioning, qualification and validation. Our tailored solutions are designed to help our clients navigate complex regulatory requirements and optimize their CQV processes to meet industry standards efficiently and effectively.
Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1)
Job Type
Senior
Workspace
Hybrid
About the Role
This role involves overseeing the development and execution of CQV strategies, managing client relationships, and ensuring compliance with regulatory requirements. The Associate Director CQV engages in strategic initiatives, provides specialized expertise, and supports client project teams. As a CQV Subject Matter Expert (SME), they play a crucial role in internal knowledge sharing, proposal development, and training content creation. The ideal candidate is recognized within the industry for their expertise, thought leadership, and robust network. The Associate Director CQV should be able to drive business growth and lead successful project delivery.
Responsibilities:
Leadership & Strategy:
Lead and manage a team of CQV Project Managers (PMs), engineers, and contractors to ensure high performance and effective resource allocation.
Act as the SME in multiple disciplines and provide guidance to clients, internal senior management, and project teams.
Develop and implement internal CQV strategies, policies, and procedures.
Stay updated on industry trends, best practices, and regulatory changes, and incorporate them into SOKOL's CQV strategies.
Actively engage in industry forums, speak at conferences, and contribute articles to establish thought leadership in CQV, wherever possible.
Build and maintain a robust network of industry contacts to enhance SOKOL's recognition as a CQV expert.
Project Oversight & Client Relationship Management:
Serve as the primary SOKOL CQV representative, embodying the company's values and expertise in all client interactions to ensure positive, professional, and productive engagements.
Oversee the planning, execution, and documentation of SOKOL’s CQV projects, ensuring timelines, budgets, and quality standards are met.
Collaborate with PMs and other stakeholders to integrate CQV activities into overall project plans.
Be prepared to take on the PM role as necessary.
Offer consulting services to clients, delivering top-tier CQV solutions tailored to their specific needs.
Participate in strategic projects that pave the way for larger team engagements or provide specialized expertise within broader initiatives.
Provide expert guidance and oversight to client project teams during project initiation and implementation.
Business Development:
Collaborate with Business Development team to Identify and pursue new business opportunities by researching organizations and individuals.
Enhance the value of existing client relationships through exceptional service delivery, while attracting new clients through industry engagement and networking.
Internal Support & Knowledge Transfer:
Serve as an internal resource for CQV expertise, supporting proposal development, internal qualifications, and training programs.
Mentor and develop team members, creating and delivering upskill training content to enhance organizational capabilities.
Draft and review high-quality, consistent CQV estimates and proposals.
Regulatory Compliance & Quality Assurance:
Ensure that all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA, etc.) as well as the internal and client's GMP standards.
Oversee and participate in the development, review, and approval of CQV documentation.
Support both internal and external audits, inspections, and regulatory submissions related to CQV.
Implement continuous improvement initiatives to enhance the efficiency and effectiveness of CQV processes.
Budgeting & Resource Management:
Develop and manage the CQV budget, ensuring cost-effective use of resources.
Monitor project expenses and ensure they align with financial goals.
Manage the purchase, maintenance, and calibration of test equipment.
Team Development:
Mentor and develop CQV team members, fostering a culture of learning, innovation, and excellence.
Identify training needs and provide opportunities for skill development within the CQV team.
Promote cross-functional collaboration and knowledge sharing across the organization.
Vendor & Contractor Management:
Manage relationships with external CQV service providers, ensuring that deliverables meet SOKOL standards and regulatory requirements.
Evaluate and select vendors, negotiate contracts, and monitor performance throughout project lifecycles.
Social and Environmental Performance:
Incorporate sustainability practices into the CQV process, including energy efficiency, waste reduction, and resource conservation.
Evaluate the environmental impact of CQV activities and implement strategies to minimize carbon footprint and waste generation.
Engage with project teams to promote social responsibility, ensuring that projects contribute positively to the communities in which they operate.
Support initiatives that align with Sokol GxP Services’ commitment to social equity, including workforce diversity and local community engagement.
Continuous Improvement:
Promote continuous improvement initiatives within CQV processes.
Implement best practices and innovative solutions to enhance efficiency and quality.
Evaluate project outcomes and apply lessons learned to future projects.
Working Conditions*
*The role may require occasional travel to project sites and vendor locations.
*The role may involve working in cleanroom environments and adhering to strict safety and quality protocols.
Salary range:
$120,000 - $150,000 per year
Benefits:
PTO
Health Insurance
Paid Holidays
Relocation Bonus
Company Laptop
Work Authorization:
Applicants must have the legal right to work in the United States without needing sponsorship.
Target Hiring Date
Immediately
Salary
$120,000 - $150,000 Per Year
Requirements
A minimum of a Bachelor's degree in engineering, life sciences, or a related field is required. A Master’s degree is preferred.
Professional certifications in CQV, Engineering, Project Management (PMP), or Quality Management (e.g., ASQ) are advantageous.
At least 10 years of experience in CQV roles in the pharmaceutical, biotechnology, cell therapy, medical device, or life sciences industry is required, with at least 5 years in a leadership position.
SME knowledge in multiple disciplines such as: Automation, Computer System Validation, Contamination Control, Clean Utilities, CTU, Facility, Manufacturing Equipment, Packaging Equipment, Sterilization, etc.
In-depth knowledge of regulatory requirements (FDA, EMA, ICH, ISO, etc.) and GMP standards is necessary.
Proven experience in managing complex CQV projects from concept to completion is essential.
Strong leadership, communication, and interpersonal skills are required.
Candidate must be able to manage multiple priorities in a fast-paced environment.
Experience with risk-based validation approaches and continuous improvement methodologies is expected.
Experience with digitalization of CQV processes and tools (e.g., electronic validation management systems such as Kneat, VEEVA, Valgenesis, etc.) would be beneficial.
About the Company
SOKOL GxP Services is a growing Commissioning Qualification Validation (CQV) and GMP service provider for pharmaceutical, biotechnology, cell therapy and medical device companies. Our primary goal is to help our clients achieve regulatory compliance and ensure the quality and safety of their products. We have a team of experienced professionals that offers comprehensive CQV services, including equipment, utilities, and facility commissioning, qualification and validation. Our tailored solutions are designed to help our clients navigate complex regulatory requirements and optimize their CQV processes to meet industry standards efficiently and effectively.