Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Role
This operational quality leadership position drives quality excellence across the business unit. The role encompasses comprehensive ownership of quality processes, documentation standards, and regulatory compliance while serving as the primary quality liaison for key customer relationships and critical quality initiatives.
Key Responsibilities:
Quality Leadership & Strategy
- Lead the development and execution of quality operations, overseeing all batch manufacturing record generation, and review. Responsible for all production related quality assurance
- Partner with peer Quality Managers and Quality Systems Manager to drive QA optimization strategies and generate company-wide continuous improvement initiatives
- Establish cross-functional quality training frameworks and capability development programs across all sites to ensure operational resilience and scalability
Process Excellence & Compliance
- Own the comprehensive governance of quality documentation systems, driving standardization, updates, and maintenance of all quality-related forms and records
- Authorize and oversee deviation management and investigation protocols, ensuring swift resolution of process and product quality issues while maintaining customer satisfaction
- Ensure unwavering adherence to GMP standards and customer quality agreements, positioning the organization as a trusted quality partner.
Team Leadership & Development
- Provide direction and leadership to the quality operations team (~10 direct reports), establishing performance frameworks and operational excellence standards
- Implement performance management systems that drive accountability and continuous improvement in batch completion metrics and quality indicators
- Champion a culture of quality excellence through regular coaching, mentoring, and professional development initiatives
Operationaxc
- Execute systematic GEMBA leadership walks to assess operational standards, drive housekeeping excellence, and ensure comprehensive GMP compliance across all operations
- Oversee product inspection protocols and quality assessment frameworks, ensuring adherence to specification requirements and proactive issue resolution
- Direct quality operations across incoming goods receipt and related supply chain touchpoints
Customer & Stakeholder Management
- Lead high-level customer engagement initiatives, representing the organization in quality discussions and driving customer satisfaction through proactive quality partnership
- Serve as a leader for customer audit processes, ensuring successful outcomes and continuous relationship strengthening
- Champion process improvement initiatives and operational innovation projects, including transfer of new product introduction initiatives.
Subject Matter Expertise
- Establish and maintain deep technical expertise in packaging and quality processes, serving as the go-to authority for customer and regulatory audit support
- Drive project leadership and cross-functional collaboration to meet evolving business requirements and organizational objectives
Essential
- Minimum 10 years’ experience in Quality for a pharmaceutical company operating to EU GMP standards.
- 2 -5 years’ experience in a leadership or team management role
- Broad and deep understanding of EudraLex Vol 4, its key chapters and annex's
- Understanding of serialisation requirements.
- A flexible and willing attitude
- Communication skills to interact with internal and external customers at a senior level.
- Strong Team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, customers and suppliers
- Design and develop new equipment to help improve line effectiveness.
- Ability to influence and collaborate at all levels in order to achieve company targets.
- Ability to represent the company in a professional and highly competent manner.
- Able to multitask and prioritise activities.
- Ability to work on their own as well as part of a team.
- Excellent problem-solving skills.
- Dependable, reliable and robust personal integrity.
Desirable
- Experience in a quality operations department, with responsibility for batch release in support of a Qualified Person Function
- Experience in hosting regulatory inspections
- Detailed understanding of both primary and secondary packaging processes.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
