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Head of North America Quality job

Galderma LaboratoriesFort Worth, TX
Galderma Laboratories jobs

Company

Job Description

The Head of North America Quality is responsible for integrating quality practices in affiliates (USA and Canada) to ensure compliance with local and international regulatory requirements. This role will also identify and mitigate issues and risks, highlight improvement opportunities and facilitate the development of solutions. The Head of North America Quality will also ensure the right talents are in place and appropriate resources allocated to achieve compliance in-line with NSH vision and values, as well as develop the skills, capabilities and expertise of the talents in the team across the region stimulating the integration and collaboration between the territories.

Develop the skills, capabilities and expertise of the talents in the team across the region stimulating the integration and collaboration between the territories. Ensure the right talents are in place and appropriate resources allocated to achieve quality compliance in-line with NSH Global Quality vision and values.

Serve as the primary Regional Affiliate Quality contact for operational matters and collaborate with local operations and management to ensure that processes are aligned with prevailing international or corporate requirements.

Facilitate integration of key GXP practices across regional affiliates to ensure quality compliance

Ensure product release and local product repackaging are performed according to applicable requirements and corporate procedures.

Enhance quality management of local licensing partners, distributors, and other GxP service providers (e.g. local contract manufacturing organizations, wholesalers, local literature review, safety case management, etc.) by establishing and keeping up to date Technical Quality Agreements

Ensure that local audits and self-inspections are performed within the Affiliate organization and at 3rd parties, as appropriate. Ensure that any deficiencies identified through audits or other means are addressed through the timely implementation of effective appropriate corrective and preventive actions.

Ensure Affiliate readiness for all GXP regulatory inspections.

Provide input as quality SME (subject matter expert) into affiliate specific process improvements and collaborate in formalizing the processes.

Champion processes which promote compliance and implement working groups with engagement from Local teams

Connect internal and external stakeholders (eg. QA, SIG, -RA, MTO, PV etc.) with Local Quality organizations to facilitate an holistic approach of GxP regulatory compliance

Manage the local Quality organization to deliver best in class service and ensure implementation, maintenance and upgrading of the local Quality System - internal audits/self-inspection, change control, deviation and CAPAs management, management reviews - in order to drive compliance of all relevant cGXP with local/International regulatory requirements and NSH global standard operating procedures

Ensure quality governance and quality planning in the Territories through the establishment and implementation of a Quality Plan, Key Quality Indicators, and Quality Risk Management Assessments.

Travel & Residency

Fort Worth, TX Minimum 15 years experience a pharmaceutical, medical device, consumer industry

Minimum 10 years experience in Quality Management.

English fluent both written and oral communications

MS Office (Excel, Power Point), eDocument Management, Training, CAPAs, Audit systems and tools

Ability to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.

Strong auditing capabilities and skills.

Root cause and risk management/assessment skills

Ability to effectively interact with and influence senior internal and external personnel on many aspects of project and product and quality related matters.

Ability to manage projects/ activities across regional geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.

Excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.

Ability to generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental/company vision.

Ability to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.

Ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way
Associated topics: business, compliance, compliance office, corporate, internal, lawyer, legal affairs, legal department, llp, market

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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Company OverviewGalderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care...Read more
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Closed Job Filters

Vice President Sales, Prescription BusinessGalderma LaboratoriesFort Worth, TX
Position Overview Duties and Responsibilities The Vice President, Sales is a key member of the US Prescription Business Unit Leadership team and will report directly to the Vice President / GeneralRead more
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Duties and Responsibilities The Director, North America Procurement has the critical objective to build, lead, and develop the NA Procurement organization across functions, including building andRead more
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Position Overview The Director, Commercial Analytics will use analytical, financial and quantitative methods to understand, track and measure customer behavior. This role will be responsible forRead more
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Position Overview The Director, Commercial Analytics will use analytical, financial and quantitative methods to understand, track and measure customer behavior. This role will be responsible forRead more
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The Director Restylane will report directly to the Senior Director of Aesthetics Marketing, and will serve as a key member of the aesthetic leadership team. He/she will have responsibility for leadingRead more
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