STAQ Pharma is currently hiring a Director of Quality for our Denver facility

Salary: $130K-$180/year
The Director of Quality is a senior-level management position responsible for overseeing and ensuring the quality, compliance, and regulatory aspects of pharmaceutical manufacturing operations. This role is crucial in maintaining adherence to established quality standards, implementing quality control measures, and fostering a culture of continuous improvement throughout the organization. The Director of Quality works closely with cross-functional teams, regulatory agencies, and stakeholders to ensure the highest level of product quality and regulatory compliance.

Qualification and Education Requirements:

• Develop and implement a comprehensive quality management system (QMS) that aligns with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.
• Establish quality objectives, policies, and procedures to guide the organization in meeting quality and compliance goals.
• Provide leadership and strategic direction to the quality team, including hiring, training, mentoring, and evaluating staff members.
• Oversee and manage the quality assurance (QA) and quality control (QC) functions, ensuring timely and accurate testing, inspection, and release of pharmaceutical products.
• Collaborate with cross-functional teams, such as manufacturing, research and development, regulatory affairs, and supply chain, to ensure effective integration of quality processes across all stages of product development and manufacturing.

Conduct regular audits and assessments to identify areas of improvement, non-compliance, and potential risks. Develop and implement correct􀀫ve and preventive action plans as necessary.
Maintain up-to-date knowledge of relevant regulations, industry guidelines, and quality best practices. Ensure compliance with applicable laws, regulations, and standards, such as FDA, State Boards of Pharmacy, and other regulatory agencies.

• Serve as the prima1y point of contact for regulatory agencies and lead inspections and audits. Ensure timely and accurate responses to regulatory inquiries and observations.
• Collaborate with external partners, suppliers, and contract manufacturers to ensure the quality and compliance of incoming materials, processes, and finished products.
• Monitor key quality performance indicators (KP Is) and metrics to assess the effectiveness of the QMS and drive continuous improvement initiatives.
• Lead and support investigations of quality incidents, deviations, out-of-specification results, and customer complaints. Develop appropriate corrective and preventive actions to address root causes.
• Participate in the development and execution of risk management strategies, including the identification, assessment, and mitigation of quality and compliance risks.
• Collaborate with senior management to develop and manage the quality department\’s budget, r􀁆source planning, and strategic initiatives.

Bachelor\’s degree in pharmacy, pharmaceutical sciences, chemist1y, or a related field . Advanced degree (e.g., Pharm.D., Ph.D.) is preferred.
Extensive experience (5+ years) in quality assurance and quality control within the pharmaceutical industry, with progressively increasing levels of responsibility.
Strong knowledge of cGMP, FDA regulations, !CH guidelines, and other relevant quality standards and regulations.
Demonstrated track record of successful interactions with regulatory agencies, including FDA inspections and audits.
Experience in pharmaceutical manufacturing processes, analytical testing methods, and quality risk management.
Excellent understanding of quality systems, quality assurance, quality control principles, and quality metrics.
Strong analytical, problem-solving, and decision-making skills .
Exceptional interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams and stakeholders at all levels.
Detail-oriented mindset with a focus on accuracy and compliance .
Ability to adapt to changing priorities and manage multiple projects simultaneously .
Professional certifications in quality management, such as Certified Quality Auditor (CQA) or Certified Quality Manager (CQM), are advantageous.

Preferred Skills:

Leadership: Strong leadership skills are essential for this role. The ability to inspire and motivate a team, provide clear direction, and drive a culture of quality and compliance is crucial.
Regulatory Expertise: In-depth knowledge of regulatory requirements and experience in dealing with regulatory agencies, such as the FDA, State Boards of Pharmacy, and other regulatory bodies, is highly desirable. Familiarity with regulatory submissions, inspections, and audits is a significant advantage.
Quality Management Systems: Proficiency in implementing and maintaining robust Quality Management Systems (QMS) in accordance with cGMP and industry best practices is preferred.
Pharmaceutical Manufacturing: A strong understanding of pharmaceutical manufacturing processes, including formulation, production, packaging, and distribution, is valuable. Experience in sterile manufacturing, aseptic processing, or biologics manufacturing is advantageous.
Analytical and Problem-Solving Skills: Strong analytical skills, attention to detail, and the ability to analyze complex data, identify trends, and make data-driven decisions are important in maintaining and improving product quality.
Communication and Collaboration: Excellent communication skills, both written and verbal, are essential for effectively collaborating with cross-functional teams, regulatory agencies, and external stakeholders. The ability to influence and negotiate is valuable.
Risk Management: Experience in risk assessment methodologies and tools, such as FMEA (Failure Mode and Effects Analysis) or risk-based decision-making, is beneficial. The capability to identify and mitigate quality and compliance risks is important.
Training and Development: Experience in developing and delivering training programs related to quality and compliance is advantageous. The ability to educate and promote a culture of quality throughout the organization is beneficial.
Industry Knowledge: Stay updated on industry trends, emerging technologies, and advancements in pharmaceutical quality and compliance. Active involvement in

JOB DESCRIPTION
professional organizations and participation in relevant conferences or seminars is desirable.
Project Management: Proficiency in project management principles and methodologies to effectively plan, execute, and monitor quality-related projects is beneficial.
Adaptability: The pharmaceutical industry is subject to evolving regulations and market dynamics. The ability to adapt to changing priorities, manage ambiguity, and navigate complex challenges is highly valued.