Chief Quality Assurance Officer – cGMP for Hybrid Products | Parsippany, NJ

 

Chief Quality Assurance Officer – cGMP for Hybrid Products | Parsippany, NJ

Are you a strategic quality leader with deep expertise in cGMP compliance and hybrid product manufacturing? We are seeking a Chief Quality Assurance Officer (CQAO) to join a forward-thinking company in Parsippany, NJ. This pivotal role offers the opportunity to lead quality assurance excellence, ensure regulatory compliance, and support innovation in the evolving hybrid product space. If you thrive in a regulated environment and have a passion for building robust quality systems, this role is tailor-made for you.

Lead Quality Assurance for Hybrid Products in Parsippany, NJ

Our client, a leader in hybrid product development and manufacturing, is looking for a Chief Quality Assurance Officer to drive the company’s commitment to current Good Manufacturing Practices (cGMP). The ideal candidate will bring extensive experience in quality systems leadership, regulatory strategy, and cross-functional collaboration. If you excel at fostering a culture of quality and compliance while supporting scalable growth, this is your chance to lead a critical function at the forefront of industry innovation.

Key Responsibilities of the Chief Quality Assurance Officer – cGMP for Hybrid Products

Quality Leadership & Compliance: Develop and maintain a comprehensive quality assurance strategy that ensures strict adherence to current Good Manufacturing Practices (cGMP) across all hybrid product lines. Lead the continuous improvement of quality systems, policies, and procedures to meet regulatory and industry standards.

Regulatory Oversight: Oversee all regulatory compliance activities related to hybrid product manufacturing, including audits, inspections, and documentation. Ensure timely responses to regulatory agencies and implement corrective and preventive actions (CAPA) as needed to mitigate risk.

Cross-Functional Collaboration: Partner closely with R&D, manufacturing, supply chain, and operations teams to embed quality by design principles throughout the product lifecycle. Facilitate open communication channels to proactively identify and resolve quality issues.

Risk Management & Quality Assurance: Establish robust risk management frameworks to identify, assess, and control potential quality and compliance risks. Lead root cause investigations and drive effective remediation plans to safeguard product integrity.

Quality Metrics & Reporting: Define, track, and analyze key quality performance indicators (KPIs) to monitor compliance and operational effectiveness. Provide transparent reporting to executive leadership and stakeholders on quality status and improvement initiatives.

Training & Development: Champion quality culture by designing and delivering training programs that enhance employees’ understanding of cGMP requirements and quality standards. Promote accountability and continuous learning throughout the organization.

Supplier & Vendor Quality Management: Oversee supplier qualification, audits, and performance monitoring to ensure the highest quality standards are met within the supply chain. Collaborate with procurement to enforce quality agreements and corrective actions.

Innovation & Continuous Improvement: Lead initiatives to leverage technology and best practices to advance quality assurance capabilities. Drive process optimization and implement systems that increase efficiency while maintaining compliance.

What the Client is Looking for in You

As the Chief Quality Assurance Officer (CQAO) for Hybrid Products, the client seeks a seasoned quality leader with deep expertise in cGMP compliance and hybrid product manufacturing. You should be a strategic, detail-oriented executive who excels at building and maintaining high-quality standards while driving continuous improvement and regulatory adherence.

Proven Expertise in cGMP and Hybrid Product Quality

The ideal candidate will have extensive experience managing quality assurance programs within regulated environments, particularly in hybrid or combination product sectors. A demonstrated ability to lead successful audits, regulatory inspections, and implement rigorous quality systems is essential.

Strategic Quality Leader with Strong Regulatory Insight

You must be capable of developing and executing comprehensive quality strategies aligned with business goals, regulatory requirements, and industry best practices. The client values leaders who anticipate regulatory changes, mitigate risks proactively, and ensure ongoing compliance.

Analytical Thinker with a Focus on Risk Management

Strong skills in risk assessment, root cause analysis, and corrective action implementation are critical. You should bring a data-driven mindset to quality metrics and continuous improvement efforts, helping to drive operational excellence across the organization.

Collaborative Partner Across Functions

The client values a leader who can work effectively with R&D, manufacturing, supply chain, and regulatory teams to embed quality into every stage of the product lifecycle. Your ability to foster a culture of quality and accountability across diverse teams will be key.

Excellent Communication and Stakeholder Management

Effective communication with internal teams, executive leadership, regulatory bodies, and external partners is vital. You should be confident in presenting complex quality data clearly and building trust with all stakeholders.

Commitment to Innovation and Continuous Improvement

The role demands a proactive approach to integrating new technologies and quality methodologies that enhance compliance and efficiency. The client seeks a CQAO who drives innovation while maintaining the highest quality standards.

FAQs About the Role – Chief Quality Assurance Officer – cGMP for Hybrid Products

1. What are the key responsibilities of the Chief Quality Assurance Officer in this role?

As the Chief Quality Assurance Officer, you will be responsible for developing and executing the company’s quality assurance strategy, ensuring full compliance with cGMP regulations, managing regulatory audits, and driving continuous improvement initiatives. You will oversee quality systems, risk management, supplier quality, and collaborate across departments to maintain the highest product standards.

2. What qualifications and experience are required for this position?

The ideal candidate should have extensive experience in quality assurance within regulated industries, especially in cGMP-compliant hybrid product manufacturing. Proven success in managing regulatory inspections, quality system implementations, and risk mitigation is essential. A degree in life sciences, engineering, or a related field is preferred, along with certifications in quality management (e.g., ASQ CQE, CQA).

3. What leadership qualities are essential for this role?

The client seeks a strategic thinker with strong analytical skills, attention to detail, and the ability to lead cross-functional teams. Excellent communication and stakeholder management skills are critical, as is the ability to foster a culture of quality and compliance. You should be proactive, solutions-oriented, and capable of driving change in a dynamic environment.

4. What challenges can I expect in this role?

You will face challenges such as navigating complex regulatory requirements, managing quality risks in hybrid product manufacturing, and aligning quality initiatives with business goals. Balancing innovation with compliance and responding effectively to audit findings and supplier issues will be key to success.

5. How will my impact as CQAO influence the company’s success?

Your leadership will directly affect product quality, regulatory compliance, and customer trust. By ensuring robust quality systems and fostering continuous improvement, you will help the company achieve operational excellence, reduce risk, and support sustainable growth in a competitive market.

6. What is the company’s culture and work environment like?

The company values a collaborative and quality-focused culture, encouraging innovation and accountability. You will work in a fast-paced, evolving environment with teams committed to excellence and regulatory compliance, supported by leadership that prioritizes quality as a core business pillar.

What Remuneration Can You Expect from This Job?

As the Chief Quality Assurance Officer (CQAO) for cGMP Hybrid Products in Parsippany, NJ, you can expect a comprehensive and competitive compensation package designed to attract experienced quality leadership in the regulated manufacturing sector. The remuneration typically includes:

1. Base Salary

The base salary for a senior Quality Assurance executive in the pharmaceutical and hybrid product industry varies based on company size, complexity of operations, and geographic location. For a mid-to-large-sized organization, annual base salaries generally range from $180,000 to $300,000 or higher, reflecting the seniority and responsibility of the role.

2. Performance-Based Incentives

Many companies offer annual bonuses tied to achievement of quality goals, regulatory compliance milestones, and overall business performance. These performance-based incentives can range from 20% to 50% of the base salary, rewarding successful leadership in maintaining product integrity and operational excellence.

3. Equity & Long-Term Incentives

Some employers provide equity awards, stock options, or long-term incentive plans that align your compensation with company growth and shareholder value. These incentives promote retention and offer significant long-term financial benefits in organizations focused on innovation and expansion.

4. Benefits & Perks

The role typically comes with a comprehensive benefits package, including:

• Health, dental, and vision insurance

• Retirement plans such as 401(k) with company matching

• Paid time off and holidays

• Professional development support and certifications reimbursement

• Wellness programs and employee assistance resources

5. Signing Bonuses & Relocation Assistance

Depending on the candidate’s experience and market demand, signing bonuses and relocation packages may be offered to facilitate transition and reward joining the company. These can range from $10,000 to $50,000 or more, particularly for candidates relocating to the Parsippany, NJ area.

Total Compensation Potential

When factoring in base salary, bonuses, equity incentives, and benefits, total compensation for this Chief Quality Assurance Officer role typically ranges from approximately $220,000 to $400,000 annually, depending on experience and company scale. Senior leaders in high-growth or publicly traded companies may see even greater remuneration opportunities.

How to Apply

If you are an experienced quality assurance leader with deep expertise in cGMP compliance and hybrid product manufacturing, we invite you to apply for the Chief Quality Assurance Officer (CQAO) position in Parsippany, NJ. This is a unique opportunity to lead quality assurance initiatives, ensure regulatory compliance, and drive operational excellence in a highly regulated environment.

To apply, please submit your resume and a cover letter outlining your experience with cGMP standards, hybrid product quality management, regulatory inspections, and cross-functional leadership. Highlight your success in maintaining product integrity, managing quality systems, and leading continuous improvement efforts.

This role offers a high-impact career opportunity where you will play a critical role in safeguarding product quality, mitigating risks, and supporting the company’s growth in the hybrid products space. Apply today to advance your career as Chief Quality Assurance Officer – cGMP for Hybrid Products in Parsippany, NJ!

For more information or to explore similar quality leadership opportunities, please visit our Executive Search for Regulatory Affairs in Combination Products Page.

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Chief Quality Assurance Officer | cGMP Quality Leadership | Hybrid Products QA | Regulatory Compliance | Quality Systems Management | Risk Mitigation | Pharmaceutical Quality | Parsippany NJ Jobs