Senior Manager, MSAT

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

The Senior Manager, Technical Documentation provides strategic, technical, and operational leadership for the Manufacturing Science & Technology (MSAT) documentation function, ensuring the consistent application of cGMP requirements and documentation standards across technology transfers, new product introductions (NPI), process changes, and commercial manufacturing operations. The role establishes and governs site and segment-level documentation strategies, systems, and processes that support compliant, efficient, and scalable clinical and commercial manufacturing.

This position leads the development, oversight, and continuous improvement of Master Batch Records (MBRs), manufacturing procedures, technical reports, specifications, and associated controlled documentation. The Senior Manager serves as the technical authority for MSAT documentation, driving standardization, best practices, and governance across sites while ensuring documentation effectively supports technology transfer, process validation, manufacturing readiness, operational excellence, and regulatory compliance.

The role provides leadership for complex cross-functional initiatives, partnering closely with MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory, and Project Management teams to resolve technical issues, implement process improvements, and ensure successful execution of new and existing clinical and commercial programs. The position is responsible for establishing documentation governance, monitoring performance metrics and quality trends, assessing compliance risks, and driving continuous improvement initiatives that enhance product quality, inspection readiness, and operational efficiency.

As a key advisor to site and segment leadership, the Senior Manager develops long-term strategies, organizational capabilities, and documentation processes that align with business objectives, regulatory expectations, and growth plans. The position fosters a culture of technical excellence, compliance, and continuous improvement while enabling successful technology transfer, accelerated product introduction, and sustainable manufacturing performance across the network.

Essential Duties and Responsibilities

• Establish and govern site and segment-wide MSAT documentation strategies, standards, and processes to support technology transfer, new product introduction (NPI), process validation, commercial manufacturing, and regulatory compliance.

• Provide strategic, technical, and operational leadership for the Technical Documentation function, ensuring consistent application of cGMP requirements and documentation best practices across the organization.

• Lead the development, review, approval, implementation, and lifecycle management of Master Batch Records (MBRs), manufacturing procedures, specifications, technical reports, and other controlled GMP documentation.

• Serve as the segment subject matter expert and technical authority for manufacturing documentation, providing guidance to MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, and Project Management teams.

• Direct documentation activities supporting technology transfers, process scale-up, process validation, new product introductions, and commercial manufacturing readiness

• Establish governance processes and performance metrics to ensure documentation quality, compliance, execution efficiency, and inspection readiness across all sites.

• Lead complex cross-functional initiatives to resolve technical, operational, and compliance challenges that impact manufacturing performance, product quality, and regulatory requirements.

• Oversee documentation-related quality events, change controls, CAPAs, deviations, and technical investigations to ensure timely resolution, effectiveness verification, and continuous improvement.

• Monitor and trend documentation, process, and compliance metrics to identify systemic issues, assess organizational risk, and implement sustainable corrective and preventive actions.

• Drive standardization, harmonization, and continuous improvement of documentation systems, templates, workflows, and governance practices across the network.

• Partner with site and segment leadership to develop long-range strategies, organizational capabilities, and operating models that support business growth, technical excellence, and operational scalability.

• Provide leadership and oversight for departmental objectives, resource planning, project prioritization, and execution to ensure alignment with corporate goals and customer commitments.

• Support internal audits, client audits, and regulatory inspections by ensuring documentation systems remain compliant, inspection-ready, and aligned with current regulatory expectations.

• Mentor, develop, and lead Technical Documentation personnel while fostering a culture of accountability, continuous improvement, technical rigor, and operational excellence.

• Represent the organization during client interactions, governance forums, technical reviews, and executive leadership discussions involving product transfers, manufacturing readiness, compliance strategy, and process improvement initiatives.

• Develop and maintain strong collaborative relationships with internal stakeholders and external partners to ensure successful execution of technical and business objectives.

• Ensure compliance with all applicable PCI policies, cGMP regulations, quality standards, and Environmental Health and Safety (EHS) requirements.

Qualifications

• Bachelor’s degree in Life Sciences discipline or equivalent experience required.

• Minimum of seven (7) years of experience in aseptic manufacturing environments, microbiology or quality assurance.

• Minimum of three (3) plus years of leadership/supervisory experience.

• Must have an expert level of knowledge in global pharmaceutical cGMP’s.

• Has expert level understanding of equipment, systems and technologies that enable issues to be translated using accurate documentation.

• Must be able to manage and lead in developing solutions to complex problems that require an in-depth degree of ingenuity, creativity, and innovativeness.

• Detail oriented and expert written and verbal communication skills.

• Ability to work autonomously, within prescribed guidelines, or as a team member.

• Must be able to manage and lead in developing employees and provide an environment that encourages development potential.

• Must be highly proficient at using Microsoft Office applications.

• Directs and provides expert knowledge of MSAT documentation strategies, standards, and processes to support technology transfer, new product introduction (NPI), process validation, commercial manufacturing, and regulatory compliance.

• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.

• Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.

• Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.

The base salary hiring range for this position is $133,920 - $150,660 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).

#LI-AK2

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.