Job DescriptionThe Quality Director will serve as the strategic and operational leader of BioTechnique's Quality function, overseeing all aspects of Quality Assurance, Quality Control, Compliance, and Validation. This role is responsible for ensuring that BioTechnique maintains the highest standards of regulatory compliance, product quality, and operational excellence across sterile injectable manufacturing, lyophilization, and clinical logistics.
The Quality Director will lead internal QA/QC teams and manage external consultants, driving cross-functional collaboration to resolve quality events, optimize validation processes, and support manufacturing operations in cleanroom environments. This individual will provide on-the-floor quality guidance, mentor junior staff, and ensure alignment with evolving regulatory expectations and sponsor requirements.
In addition to core quality responsibilities, the Quality Director will play a pivotal role in supporting Business Development (BD) initiatives, Manufacturing Science and Technology (MSAT) projects, and internal product approvals. The role includes project management responsibilities for selected customer programs and strategic input into sponsor engagement and innovation adoption.
- Provide strategic leadership and independent QA oversight across all cGMP-regulated areas, including:
- Critical utilities (WFI, Steam, Automation, HVAC, equipment)
- Warehouse operations
- Manufacturing processes
- Inspection, labeling, and packaging
- Batch record review and disposition
- New product introduction and product transfer
- External laboratories and supplier quality
- Lead and manage BioTechnique's quality assurance, compliance, and validation activities, ensuring alignment with FDA, EMA, and international regulatory standards
- Execute tactical QA operations while overseeing and mentoring junior staff in real-time floor assessments, issue identification, documentation, and resolution
- Perform independent technical review of documentation during and post-execution of cGMP activities, ensuring specifications and requirements are met
- Provide guidance and training across GMP areas (Manufacturing, QC, Validation) to ensure regulatory compliance and continuous improvement
- Sign off, qualify, and train junior staff on QA/QC/Validation responsibilities and ensure readiness for regulatory inspections
- Analyze findings and report to relevant departments; drive corrective actions and preventive measures through CAPA and deviation management systems
- Serve as Subject Matter Expert (SME) for internal and external audits, regulatory inspections, and client engagements; lead inspection readiness activities
- Maintain the approved supplier list and oversee external vendor compliance and investigations
- Lead validation projects and ensure systems, processes, and documentation meet regulatory and internal standards
- Provide quality oversight for change management systems, including complex Minor and Major Change Controls, ensuring stakeholder alignment and regulatory compliance
- Suspend operations when necessary and act as final decision-maker on critical compliance determinations
- Foster collaboration across QA/QC/Validation/Warehouse teams and promote a culture of quality and accountability
- Mentor, coach, and train personnel at all levels; support development and implementation of training programs
- Establish and refine QA processes and procedures to ensure robust compliance with cGMP operations
- Manage PSC consultants supporting BioTechnique, ensuring alignment with project goals and compliance initiatives
- Support Business Development (BD) and MSAT initiatives with quality strategy, technical input, and sponsor-facing engagement
- Drive preparation for Pre-Approval Inspections, regulatory audits, and submissions
- Communicate effectively with clients, vendors, and cross-functional teams to resolve investigations and ensure compliance
- Stay current with evolving regulatory requirements and advise BioTechnique on necessary adaptations
- May serve as consultant on external client projects, as needed
- Perform other duties as required to support BioTechnique's mission and operational success.
Requirements- Bachelor's degree or higher from an accredited four-year university, preferably in life sciences, engineering, or a related technical field
- Advanced degree (MS, MBA, or equivalent)
- Minimum of 15 years of experience in pharmaceutical quality assurance, with a focus on aseptic and sterile manufacturing
- At least 5 years of leadership experience managing teams, projects, and priorities within complex matrixed organizations
- Extensive experience in cleanroom operations, ISO standards, and cGMP environments
- Proven track record in quality assurance, regulatory compliance, and validation within pharmaceutical or biotech industries
- Advanced knowledge of FDA, EMA, and international regulatory frameworks
- Deep understanding of cGMP, ISO, and other applicable quality standards
- Experience preparing for and hosting regulatory inspections and client audits
- Strong independent judgment and decision-making capabilities
- Proven ability to lead cross-functional teams and external consultants
- Demonstrated success in driving project execution and quality improvement initiatives
- Ability to execute both strategic and tactical objectives across departments
- Skilled in mentoring, training, and developing junior staff
Demonstrated Competencies- Quality, Compliance, and Validation Oversight - Deep understanding of FDA, EMA, and global regulatory standards, skilled in risk-based validation and regulatory reporting, and ensures manufacturing and documentation meet compliance expectations.
- Team Leadership & Supervision - Supervises internal staff and external consultants, provides mentorship and training to improve team performance, and aligns team efforts with compliance goals and operational success
- Regulatory Compliance & Industry Best Practices - Stays current with evolving regulations and industry trends, advises on necessary process changes to maintain compliance, and implements best practices across quality and validation functions.
- Hybrid Leadership & Strategic Execution - Communicates effectively across PSC Biotech and BioTechnique, builds trust with cross-functional teams and leadership, and coordinates efforts between onsite and remote teams
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Perks and Discounted Rates
- Financial Perks and Discounts
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