From PCI's posting. “We” and “our” refer to the employer.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
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:
The General Manager / Site Leader is accountable to the President, Development & Manufacturing, assuming responsibility for the site, providing leadership, support and point of escalation. To deliver site commitments, drive functional excellence and ensure effective and appropriate linkages across the organization. Provide support to leaders and employees and strive for operational excellence, One PCI Culture, and continuous improvement to further enhance the site’s performance toward short and long term goals.
Essential Duties and Responsibilities:
Develop and execute the long-term strategic vision for the San Diego site, ensuring alignment between site objectives, operational priorities, and enterprise growth strategies.
Serve as a key member of the Development & Manufacturing leadership team, contributing to corporate strategy, capital investment decisions, operational excellence initiatives, and business transformation efforts.
Foster a high-performance culture that emphasizes accountability, engagement, innovation, collaboration, continuous learning, and talent development.
Build and maintain strong relationships with key customers, ensuring PCI is viewed as a trusted strategic partner and industry leader while supporting retention, growth, and customer satisfaction objectives.
Identify, assess, and mitigate operational, financial, regulatory, quality, and business continuity risks to support sustainable growth and organizational resilience.
Ensures that the capital plan is executed effectively. Directs and coordinates production and maintenance activities according to the most stringent quality, regulatory, and safety requirements.
Maintain constant focus on customer satisfaction and direct all activities to deliver a quality product on time and in full to meet customer needs. Establish a culture obsessed with customers and focused on providing the industry’s leading customer experience.
Collaborate with Business Development to foster growth with current customers and to obtain new business relationships to ensure we meet the overall company objectives and budgeted growth.
Champion PCI’s One Culture philosophy by driving employee engagement, inclusion, communication, leadership visibility, and change management initiatives throughout the organization.
Lead strategic workforce planning efforts, ensuring the site has the organizational capabilities, succession plans, leadership pipeline, and talent strategies necessary to achieve current and future business objectives.
Drive continuous improvement through the implementation of lean manufacturing principles, operational excellence methodologies, digital transformation initiatives, and best practices across all site functions.
Partner with Operations, Technical Services, Quality, Supply Chain, Engineering, Finance, and Human Resources leadership to ensure alignment of business objectives and successful execution of strategic priorities.
Promote a culture of safety, quality, compliance, and operational discipline while reinforcing PCI values and expected leadership behaviors.
Ensure appropriate leadership development and succession planning for future career growth.
Embrace and drive change and develop and implement harmonization and continuous improvement initiatives to ensure a seamless global clinical services offering by close liaison with colleagues at other clinical service locations.
Works collaboratively across boundaries to develop cross-functional resolution to issues with buy in from all levels to ensure successful change.
Oversees team culture and development through positive coaching, training, leadership, guidance, and assignment of growth opportunities.
Ensures successful audits by creating departmental ownership through participation in regulatory inspections and customer audits.
Assigns ownership to the root cause analysis and corrective actions when necessary with the appropriate follow up to ensure completion and sustainability.
Ensures a safe working environment for employees and compliance of site operations with company policy, regulatory bodies, and employment law.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Business Administration, or a related discipline required; MBA, Master’s degree, or other advanced degree preferred.
Minimum of 15+ years of progressive leadership experience within the pharmaceutical, biotechnology, CDMO, or other highly regulated manufacturing industries, including significant executive-level operational leadership responsibilities.
Proven track record of leading sterile fill-finish manufacturing organizations, delivering sustained operational excellence, regulatory compliance, quality performance, and financial results.
Demonstrated success managing complex manufacturing operations with full accountability for P&L performance, strategic planning, capital investments, customer satisfaction, and business growth.
Extensive experience building and leading high-performing, cross-functional organizations, including talent development, organizational design, succession planning, and leadership team effectiveness.
Strong knowledge of current FDA, EMA, MHRA, and other global regulatory requirements governing pharmaceutical manufacturing, quality systems, and cGMP operations.
Demonstrated ability to develop and execute business strategies that drive growth, expand capabilities, improve profitability, and strengthen competitive market position.
Proven experience leading large-scale transformation, operational excellence, continuous improvement, and change management initiatives across complex organizations.
Exceptional executive presence with the ability to influence and build relationships with customers, board members, investors, regulators, industry partners, and senior leadership teams.
Strong commercial acumen with experience supporting customer acquisition, strategic account management, contract negotiations, and long-term business partnerships.
Outstanding analytical, financial, and problem-solving capabilities, with the ability to translate complex operational and business data into actionable strategies and decisions.
Excellent communication and stakeholder management skills, with the ability to effectively engage audiences ranging from frontline employees to executive leadership and external customers.
Demonstrated commitment to fostering an inclusive, high-performance culture focused on accountability, employee engagement, innovation, collaboration, and continuous development.
Advanced proficiency with business systems, ERP platforms, data analytics tools, and Microsoft Office applications.
Ability to travel domestically and internationally as required to support customer engagement, business development, site operations, and enterprise leadership responsibilities.
Benefits
For candidates in San Diego, CA, the hiring range for this position is $223,840 - $265,000 annually, plus eligibility for an annual performance bonus
Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise
PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k)
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.
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