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Manager, Clinical Quality Assurance job

Galderma LaboratoriesFort Worth, TX
Galderma Laboratories jobs

Company

Salary

Skills

Job Description

The Clinical Quality Assurance Manager is responsible for assuring the quality of clinical development systems, processes and related activities in the USA.

In close collaboration with the Audit Program Manager, develop, manage and implement in North America the Innovation Quality Audit Program dedicated to clinical development activities which covers:

Service providers (CROs, suppliers)

Internal audits (activities, processes and systems)

External and study specific audit plans

Conduct audits of Investigational sites and Service Providers for qualification routine surveillance or for cause purposes as well as Internal Audits (systems, processes, tools) and independent reviews of documents.

Act as a Clinical QA representative for the activities initiated by the three Strategic & Innovation Groups and liaise with Operational Partners to have an in depth knowledge of the clinical programs and studies, of their rationale.

Inform, as GCP Subject Matter Expert, operational partners and Quality management of any issue adversely or potentially impacting quality, compliance or safety; recommend appropriate corrective actions,

Participate to the preparation of trends analyses and recommend corrective actions.

Conduct or contribute to periodic GCP Quality reviews and to the preparation of the annual Management review.

Lead/support continuous improvement activities and conduct internal training on Quality standards and regulations.

Perform Quality Documents Review (e. g SOPs, instructions).

Perform internal training on Quality standards and regulations.

Host GCP regulatory inspections in North America.

Support the Innovation Quality Management regarding reporting tasks, definition and respect of the budget.

Manage and develop directly reporting staff.

Other duties as assigned.

Travel & Residency

Galderma Laboratories, L.P. USA Headquarters; Fort Worth, TX Seven or more years of industry (Pharmacy, Chemistry, Cosmetics, Food Processing, Medical Devices) experience and solid experience in Clinical Quality auditing.

Experience of internal and external audits in an international environment.

Familiar with procedures and the ability to apply/implement them correctly in appropriate circumstances.

Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.

Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.

Strong analytical, project management skills.

Strong knowledge of MS Office (Excel, Power Point).

Experience with eDocument Management, Training, CAPAs, Audit systems and tools.
Estimated annual salary
$83,950
average
Minimum
$68,797
Maximum
$105,175

TASKS

  • Review processing schedules or production orders to make decisions concerning inventory requirements, staffing requirements, work procedures, or duty assignments, considering budgetary limitations and time constraints.
  • Direct or coordinate production, processing, distribution, or marketing activities of industrial organizations.
  • Develop or implement production tracking or quality control systems, analyzing production, quality control, maintenance, or other operational reports to detect production problems.
  • Review operations and confer with technical or administrative staff to resolve production or processing problems.

SKILLS

  • Reading ComprehensionUnderstanding written sentences and paragraphs in work related documents.
  • Active ListeningGiving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • WritingCommunicating effectively in writing as appropriate for the needs of the audience.
  • SpeakingTalking to others to convey information effectively.

KNOWLEDGE

  • Administration and ManagementKnowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
  • ClericalKnowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
  • Customer and Personal ServiceKnowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
  • Personnel and Human ResourcesKnowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.

Galderma Laboratories

Type

Company - Private

Size

Medium

Revenue

$100M to $500M

Location

2929 Texas Longhorn WayFort Worth, TX, 76177and others

Industry

Household and Commercial Storage

Founded

1981

CEO

Humberto C. Antunes

Job Filters

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