Site Head Of Quality Jobs

Must have excellent organizational, management, and people development skills.

Develops and manages budget, organizational structure and business requirements to accommodate business needs and assure meeting JSC metrics.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

The incumbent must have 9 years QA/QC experience in the pharmaceutical industry.

Strong knowledge in regulatory compliance, Quality Systems, pharmaceutical industry, pharmaceutical methods and procedures

Must use interpersonal and teamwork skills to build interdependent partnerships.

Exceptional leadership and people management abilities, with a focus on building and developing high-performing teams

Create and monitor systems that enable the effective governance, risk management and administration of the QMS

Proven experience in the field of Clinical Laboratory Medicine that emphasizes complex testing in a high-throughput setting

15+ years of experience leading Quality Assurance/Regulatory Affairs organizations

Global business experience, including international QMS standards such as ISO9001, ISO15189 and ISO 13485

Excellent understanding of regulatory requirements and compliance standards relevant to the industry

Financial management: Expected to deliver on increase efficiency and effectiveness of the department some basic financial management skills are needed.

A minimum of 5 years with people management experience managing a large team with direct & indirect reports

Process management and enhancement: Continuously look to identify opportunities to improve departmental processes and procedures to increase efficiency and effectiveness.

Collaborates with management and senior staff across production departments.

Working knowledge of quality system requirements

Project management, Lean, Operational Excellence, Product/Process Development or Regulatory highly desirable

BS in Construction Management or Engineering or equivalent work experience.

Experience in personnel management, and staffing and scheduling.

Experience in contractor, consultant and vendor management.

Provide training of personnel to ensure awareness of quality procedures and specific responsibilities in the QA/QC process.

7+ years’ experience in quality control & quality assurance (QA/QC) programs for data centers or mission critical construction projects.

Experience with Design-Build and Design-Bid-Build construction programs.

Five to eight years direct experience in quality control management, preferably in a spring environment.

Acts as the Management Representative for Michigan Spring and Stamping’s registered quality systems.

Proven experience as a quality manager

Excellent math abilities and working knowledge of data analysis/statistical methods

Understands customer needs and requirements to develop effective quality control processes

Conducts and/or manages studies to determine cause, effect and corrective measures required to remedy deviations impairing desirable standards of quality.

10+ years of experience in quality management, preferably in the dietary supplement industry

Building and managing effective Quality Management Systems (QMS)

Overseeing Quality Assurance activities, optimizing quality management systems, change control, risk management

Ensure compliance with FDA regulatory requirements

Leading Quality Control efforts, including QC procedures and policies, analytical methods, and laboratory qualifications

Developing and executing the Quality strategy

Strong leadership and organizational skills, with experience managing teams of 10 or more people.

Manage external client relationships related to quality assurance and ensure their needs are met.

Managing a growing team of 20 to 50 technicians & managers while continuing to develop positive company culture.

Experience in managing external client relationships and working with CROs/CMOs.

20 to 50 technicians & managers while continuing to develop positive company culture.

The Head of QA should have the following qualifications….

Develop clear accountabilities and handoffs between the process development, MS&T and technical operations organizations.

BS in a scientific or related field with 10+ years progressive leadership experience in a biotechnology or pharmaceutical company

CDMO industry experience would be highly desirable.

Experience with global supply chains for biologics and/or advanced therapies

Deliver strategic leadership and vision to ensure successful scale up of client-specific manufacturing programs.

Promote scientific rigor and ensure industry-leading manufacturing operations.

Certifications in quality management (e.g., Six Sigma, Lean) are highly desirable.

Establish and maintain a robust quality management system, including documentation control, change control, and deviation management.

Strong knowledge of regulatory requirements, such as FDA regulations, GMP guidelines, and ICH guidelines.

Proven track record of implementing and managing a quality management system in accordance with industry standards.

Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle, from development to manufacturing and distribution.

Minimum of 10 years of progressive experience in quality assurance and quality control in the biotech or pharmaceutical industry.

Knowledgeable in Process Safety Management (PSM) requirements.

Experienced with ISO 14001, 9001, 45001 management systems.

Demonstrated risk management skills and business continuity planning.

Knowledgeable of Occupational Health requirements.

Five plus years progressive leadership experience focused in EHS or manufacturing operations

Knowledgeable of US EPA, OSHA, DOT and NH DES regulations.

Responsible for end-to-end Quality within the site, including FUSE qualification/validation, materials management, batch record reviews, change control, and deviations

Collaborate with internal partners to enable compliant and successful manufacturing (e.g. technology transfers, validation, testing, and lifecycle management)

Direct experience hosting Health Authority inspections

Prior experience in the manufacture of cell and gene therapy products

Provide strategic direction and operational leadership for the site Quality function at CRISPR’s internal manufacturing facility

Chair the site Quality Review Board and establish quality metrics to demonstrate adherence to GMP regulations and CRISPR procedures

2.Responsible for the operation management of the US subsidiary to realize the

provide accurate market basis for the company's management decision-making.

2. More than 5 years of sales/BD experience in Biotech & Pharmaceutical companies,

BD VP, US Subsidiary Head

1. Led the US sales team to develop customers and achieve business growth targets.

3.Analyze the market conditions of US and provide market analysis reports, and

2.Responsible for the operation management of the US subsidiary to realize the

provide accurate market basis for the company's management decision-making.

2. More than 5 years of sales/BD experience in Biotech & Pharmaceutical companies,

BD VP, US Subsidiary Head

1. Led the US sales team to develop customers and achieve business growth targets.

3.Analyze the market conditions of US and provide market analysis reports, and

2.Responsible for the operation management of the US subsidiary to realize the

provide accurate market basis for the company's management decision-making;

2. More than 5 years of sales/BD experience in Biotech & Pharmaceutical companies,

1. Led the US sales team to develop customers and achieve business growth targets;

3.Analyze the market conditions of US and provide market analysis reports, and

4.Lead the team to search for business development clues, complete the

Experience with Track Wise Deviation/CAPA, Change Control Management (CCM), SAP and DMAIC philosophy.

Drive digital innovation within Quality Management Systems

Conduct gap analyses and implement Quality Management System procedures

Oversight of all business monitoring type activities, including Quality Council, Management Review, Annual Product Quality Review (APQR) and associated processes.

Establish sustainable business processes are in place for all Quality Management Systems.

Follow domestic and international GMP regulations, cGMP’s, company policies, Takeda leadership behaviors, and conducting performance management

Accountable for timely notification and effective management of internal and Client-related changes

Comprehensive knowledge of global GMP regulatory requirements for cell & gene therapy products

Experience with facility commissioning and qualification

Provides compliance and strategic guidance during the design and qualification of the plant expansions.

Manages effectively the site’s GMP training program. Champions initiatives for continued learning and development.

Develops and manages departmental goals and corresponding budget in alignment with corporate vision and goals

Knowledge and understanding of pharmaceutical quality management systems and drug manufacturing.

Skilled in project management and ability to problem solve utilizing a collaborative approach to resolutions.

Regulatory knowledge relating to approval and maintenance of drug applications, regulatory submission process and requirements, including post marketing requirements.

Demonstrated proficiencies with auditing, and CAPA (corrective and preventive action) development/management.

Establish and manage Quality policies and procedures for receipt, manufacturing, packaging, testing, documentation, storage, and transporting applicable products.

Minimum of ten years QC/QA technical pharmaceutical leadership experience.

Extensive knowledge of quality management systems and quality improvement tools and techniques such as Six Sigma or Lean.

Minimum of 2-4 years in a supervisory role in Quality Management in a certified laboratory

Identify and report quality issues and problems to management with recommendations for resolution.

Ensure sound management of laboratory operations and the development, implementation, and review of internal policies.

Quality Management Systems (50% of duties)

Management and Leadership (15% of duties)

Proven track record of developing and implementing quality management systems in compliance with regulatory requirements.

Experience in leading and managing quality assurance teams, including hiring, training, and performance management.

Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and senior management.

In-depth understanding of risk management practices and their application in the medical device industry.

Strong knowledge of class III Medical Devices

Excellent problem-solving and analytical skills, with the ability to make data-driven decisions.

Minimum 10-12 years’ experience in aseptic production/processing cleaning practices within a regulatory environment, including 5 years in a managerial role

Manage inspection readiness program and activities and provide support during regulatory inspections and customer audits.

Strong verbal and written communication skills

Strong knowledge of business process needs of quality assurance

Ability to enable and empower managers and hold them accountable for results

Supervise, coach and develop Quality staff