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Senior Manager, Validation Services

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We are seeking an innovative and highly motivated Senior Manager to oversee the Validation Services department to support the growth of the Cellares team.

The Validation team at Cellares is a global service that supports the development and maintenance of the IDMO facilities. This individual will be responsible for managing the distributed team that is providing Quality oversight of environmental, equipment (analytical and production), facility & utility, site automation, computerized systems, process validation & engineering documents, and test protocols, along with associated CAPAs, deviations, change control records, and additional site based technical documentation and activities. This individual will work closely with cross-functional teams to maintain high standards of quality in a regulated environment.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
Author and maintain the IDMO Site Validation Plan
Provide Quality oversight of process validation studies and process performance qualifications
Manage direct staff to achieve high performance and deliver quality results for Cellares’ internal and external customers
Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification & recertification, cleaning & sanitization, and facility controls
Proactively identify & resolve technical and compliance issues/gaps
Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge
Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)
Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
Act as Quality Subject Matter Expert for responsible areas/projects during client or regulatory inspections
Drive continuous improvement and increase efficiency and productivity

Requirements

Bachelor’s degree in a scientific or engineering discipline
10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
5+ years of direct experience in quality or validation, and demonstrated knowledge of relevant cGMP regulations
5+ years of managing individual contributors in quality or validation roles, or in an associated pharmaceuticals, biologics, vaccines, cell or gene therapy manufacturing environment
Excellent knowledge of the regulations for biologics, cell and gene therapy products
Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is desirable
Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
Excellent understanding of risk management and CAPA processes
Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy

$90,000 - $210,000 a year

Cellares’ total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.

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Average salary estimate

$150000 / YEARLY (est.)

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$90000K

$210000K

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What You Should Know About Senior Manager, Validation Services, Cellares

Are you looking for a dynamic role in a rapidly evolving company? Cellares is on the hunt for a Senior Manager of Validation Services to play a pivotal role in our innovative team! As a Senior Manager, you'll oversee our Validation department and ensure our IDMO facilities maintain the highest standards of quality. Your leadership will focus on managing a distributed team responsible for providing quality oversight on everything from equipment and environmental controls to process validation and technical documentation. You'll collaborate with cross-functional teams in a fast-paced environment that loves a challenge. Your responsibilities will include reviewing complex documentation supporting GMP operations, authoring the IDMO Site Validation Plan, and managing staff to achieve exceptional outcomes for both our internal and external customers. Additionally, you'll ensure compliance with industry standards while driving continuous improvements across the team. If you have a Bachelor’s degree in a scientific or engineering discipline, along with extensive experience in a GMP environment, we want to hear from you. Joining Cellares means being part of a mission-driven company that prioritizes employee well-being with competitive compensation, excellent health benefits, and opportunities for personal and professional growth. Come be part of something impactful!

Frequently Asked Questions (FAQs) for Senior Manager, Validation Services Role at Cellares

What are the primary responsibilities of a Senior Manager, Validation Services at Cellares?

The Senior Manager, Validation Services at Cellares is responsible for overseeing the Validation department, which includes managing a global team that ensures Quality oversight across multiple areas like environmental controls, equipment, and process validation. Key duties involve reviewing complex GMP documentation, authoring the IDMO Site Validation Plan, and driving continuous improvement within the validation processes. The role also includes acting as a Subject Matter Expert during client or regulatory inspections, ensuring compliance with internal procedures and global regulatory expectations.