The Role
Leads the Quality function across sterile injectable manufacturing, including QA, QC, compliance, validation, cleanroom operations, audits, inspections, CAPA, deviations, supplier quality, and change controls. Manages teams and consultants, provides floor-level quality oversight, mentors staff, supports regulatory readiness, and advises Business Development, MSAT, sponsors, and client programs on quality strategy and compliance.
Summary Generated by Built In
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.
The Experience
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.
Your Role
The 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
Benefits
Offering 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
Equal Opportunity Employment Statement
BioTechnique is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Skills Required
- Bachelor's degree or higher from an accredited four-year university
- Degree preferably in life sciences, engineering, or a related technical field
- Advanced degree such as an MS, MBA, or equivalent
- Minimum 15 years of pharmaceutical quality assurance experience focused on aseptic and sterile manufacturing
- At least 5 years of leadership experience managing teams, projects, and priorities in complex matrixed organizations
- Extensive experience with cleanroom operations, ISO standards, and cGMP environments
- Proven experience 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 applicable quality standards
- Experience preparing for and hosting regulatory inspections and client audits
- Strong independent judgment and decision-making capabilities
- Ability to lead cross-functional teams and external consultants
- Demonstrated success driving project execution and quality improvement initiatives
- Ability to execute strategic and tactical objectives across departments
- Skills in mentoring, training, and developing junior staff
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
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