Senior Director of Quality

PSC Biotech • York, PA

13d • Hybrid

About The Position

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At BioTechnique, it’s about more than just a job—it’s about your career and your future.

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
• Deep understanding of FDA, EMA, and global regulatory standards
• Skilled in risk-based validation and regulatory reporting
• Ensures manufacturing and documentation meet compliance expectations.
• Supervises internal staff and external consultants
• Provides mentorship and training to improve team performance
• Aligns team efforts with compliance goals and operational success
• Stays current with evolving regulations and industry trends
• Advises on necessary process changes to maintain compliance
• Implements best practices across quality and validation functions.
• Communicates effectively across PSC Biotech and BioTechnique
• Builds trust with cross-functional teams and leadership
• Coordinates efforts between onsite and remote teams

Nice To Haves

• Advanced degree (MS, MBA, or equivalent)

Responsibilities

• Serve as the strategic and operational leader of BioTechnique’s Quality function, overseeing all aspects of Quality Assurance, Quality Control, Compliance, and Validation.
• Ensure that BioTechnique maintains the highest standards of regulatory compliance, product quality, and operational excellence across sterile injectable manufacturing, lyophilization, and clinical logistics.
• 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.
• Provide on-the-floor quality guidance, mentor junior staff, and ensure alignment with evolving regulatory expectations and sponsor requirements.
• Support Business Development (BD) initiatives, Manufacturing Science and Technology (MSAT) projects, and internal product approvals.
• Manage project management responsibilities for selected customer programs and provide 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, and 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director