Job Description

Recruiters please do not contact this job poster. Please be advised: Solvias does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.

Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell and Gene Therapy (CGT), and Cosmetic industries. With headquarters near Basel, Switzerland, about 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

Position Overview

Located at our large molecule headquarters in RTP, North Carolina, the Senior Manager, Quality Assurance is responsible for the management and deployment of the site Quality Management System and daily Quality business functions under the oversight of the Site Quality Head. The position is an onsite role at our new facility for Large Molecule and Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC.

Critical Performance Areas

· Responsibility for the oversight, execution and maintenance of Site quality management functions and systems.

· Provide management of the US Large Molecule laboratory and Quality Management organization to deliver high quality and GxP-compliant testing services.

· Hire, develop, and manage a team of qualified Quality Assurance professionals providing quality oversight for a wide range of tools, business processes, and procedures supporting cell and gene therapy, cell-based bioassay (CBBA), physical chemistry, Molecular Biology and Virology testing.

· Ensure quality processes, procedures, and tools are fit for purpose, GxP compliant, and support analytical timelines as well as future commercial needs.

· Able to simultaneously manage several complex programs and communicate effectively with clients, regulatory authorities, and internal customers.

· Display leadership skills to direct staff and ensure adherence to appropriate regulatory requirements, including US FDA current Good Manufacturing Practices (cGMP).

· Provide timely and effective communication to impacted stakeholders across functional areas, including Quality and Site Leadership.

· Lead continuous improvement efforts for quality processes and represent a culture of quality at the site.

Essential Job Functions

· Assist with the design and deployment of the site quality management system and policies consistent with GMP/GLP principles and the organization’s mission. Define SMART objectives which support the quality system and quality objectives.

· Manage, work within and maintain site Quality systems, processes, procedures and records, including:

o Document and Records Management

o GxP Training Program

o Risk Management

o Supplier Management

o Internal Audits

o Quality Metrics and KPIs

o Incident, Deviation, OOS and CAPA Programs

o Customer and Supplier Complaints

o Risk Assessment

· Support/Lead preparation for and handling of external inspections by regulatory authorities and customer audits, including coordination of remediation actions/responses.

· Develop awareness and enforce policies to ensure the integrity of data and records generated during laboratory testing and release/approval processes.

· Establish, maintain and improve effective communication channels internally to ensure that all employees are aware of GxP requirements and externally to ensure transparency with regulatory agencies, customers, and other stakeholders.

· Create, review, and approve Quality Management System documentation and records (e.g., change control, procedures, protocols, reports, investigations, CAPA, risk assessments, etc.).

· Work closely with internal operational groups (site and commercial) and external parties (i.e., customers, suppliers) for program deliverables completion.

Requirements

· Minimum of 8 years’ experience in a pharmaceutical/biotechnology environment, with at least 3 years in a supervisory/managerial role.

· Prior experience managing direct reports and leading cross functional teams.

· Bachelor’s degree in a technical, scientific, or other relevant discipline.

· Strong knowledge of regulatory requirements (e.g., FDA, EMA, 21 CFR Parts 210/211 and 11, ICH, GMP).

· Working experience within an electronic Quality Management (eQMS) and Laboratory Information Management (LIMS) Systems (MasterControl and/or Labware LIMS are a plus).

· Experience with customer and regulatory body interactions.

· Ability to make sound quality decisions quickly and independently

Other Desired Skills/Abilities

· Site or laboratory startup experience is a plus.

· Experience within a contract organization (CRO, CDMO) desired.

· Strong foundations in risk management and continuous improvement.

· Excellent analytical and critical thinking skills.

· Strong attention to detail and organization.

· Effective communication and interpersonal skills.

NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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