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Company

Grifols · 15 hours ago

Manager, Change Control

Home, KS

Full-time

Remote

Mid, Senior Level

$97K/yr - $146K/yr

7+ years exp

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Responsibilities

Develops, implements, and manages department processes in harmony with company goals and objectives; develops departmental goals and objectives, and directs and monitors their achievement.

Leads and manages change control process improvement initiatives (e.g., monitors key performance indicators, records management, etc.).

Provides support for training initiatives as needed.

Leads and manages document changes through electronic system (DCM/LSQM).

Incorporate interactive tools for task assignment among team members.

Hires and trains staff; provides leadership and direction with respect to duties, projects, and development.

Liaises with other departments (e.g., Training, Regulatory Compliance, Information Solutions, Purchasing, Regulatory Affairs) to ensure continual alignment and improvement of shared processes.

Liaises with other business groups (e.g., collection centers, testing labs, warehouses, manufacturing sites) to achieve alignment of interrelated processes.

Provides support for quality initiatives in the field, ensuring alignment with business initiatives.

Represent Change Control on projects that impact quality systems and donor center operations and regulatory compliance.

Provides guidance to other business functional groups regarding project plans and/or change implementation to facilitate effective and compliant change.

Reports departmental key performance indicators (KPIs).

Oversees the management of the change control system that manages all changes made to vendors managed by Supplier Quality, critical supplies, GMP processes and procedures.

Assists with the development, implementation, monitoring and improvement of department quality systems.

Qualification

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Change ControlDocument ControlCGMPRecords ManagementQuality SystemsData AnalysisProject ManagementSupervisory ExperiencePharmaceutical Industry ExperiencePlasma Collection ExperienceTechnical Leadership

Required

Knowledge of records management principles and practices, and current Good Manufacturing Practices (cGMP) in a regulated environment as it applies to Change Control and Document Control.

Strong managerial and project management skills.

Demonstrated problem-solving skills.

Excellent oral and written communication skills.

Ability to prioritize competing tasks and meet deadlines.

Ability to analyze and interpret data, identify errors and implement effective corrective actions.

Technical expertise in document control and quality systems with strong emphasis on the conceptual understanding of overall operational process required to provide department with direction and oversite.

Associate's degree in chemistry, biology, physical sciences or related field or Bachelor with 5 years related experience.

Typically requires a minimum of 7 years of related experience in plasma collection or pharmaceutical industry.

Experience with design and control of documentation and quality systems.

Project or technical leadership experience required.