Senior Director Quality Jobs

5+ years of experience in Quality Engineering

Knowledge of FDA current GMP/QSR Regulation

Strong applied knowledge on statistical tools: DOE, Acceptance Sampling, SPC, etc.

Good oral and written communication skills in both English and Spanish are a must

Actively participate and assist in the planning of the Validation Strategic development for new Processes (NP) / New Technology (NT)

Provide the appropriate quality technical support to new product development and improvement projects.

Time Management: tracking/monitoring production and maintaining productivity

Extensive knowledge of principles and applications of FSQA programs including HACCP, Sanitation and applicable certifications

Develop food safety compliance strategy to align with local, city, state and federal requirements.

Lead and motivate a team of Food Safety and Quality Assurance Managers, senior managers, and supervisors across multiple facilities.

Validate and verify the adherence of sites to HACCP plans and ensure compliance with all company FSQA requirements.

Be the primary contact for high-impact food safety and quality issues experienced by the company and industry.

Prior experience and knowledge in implementing Quality Management System and electronic document control systems.

Direct development, initiation, and maintenance of all Quality Systems in support of the product(s) including the Quality Management Review.

Competence in FDA and international GMP requirements. Strong working knowledge of GCP beneficial.

Manage external consultants, as required.

Minimum of ten (10) years of Quality Assurance experience in FDA regulated industry, preferably, biologic or Antibody Drug Conjugate therapeutics.

Prior experience with IND and early clinical stage oncology programs.

Strong problem-solving and conflict management skills

Knowledge of constraint management principles

Vehicle discount program for employees and family members, and management leases

Create a conducive work environment for the team(s) to complete their assigned responsibilities / tasks

Basic administration of supervisory responsibilities and documents

Strong organizational and administrative skills

Over 5 years of management experience in a manufacturing environment, preferably in an Steelwork or Fabrication

Knowledge and/or training in ISO 9001 procedures and responsibilities preferred.

Knowledge and understanding of quality assurance procedures and measuring skills.

Manage and report on the status of the Plant quality objectives.

Knowledge of American Institute of Steel Construction (AISC) audits and standards.

Oversee the quality assurance and control processes, including inspections, testing, and auditing.

Knowledge of regulatory requirements a plus

Exceptional written and verbal communication skills.

Prioritization and negotiation skills managing quality issues with suppliers.

Extensive knowledge o the beauty industry a plus

Minimum of 5 years quality experience.

Quality audits of third party manufacturers (TPM)

Provides management of the Division Quality Departments through direction of the Quality Managers at each Division location.

Knowledge and experience to participate and serve as Company representative in military and industrial organizations.

Assures adherence to the requirements specified in Corporate Quality Assurance (CQA) procedures.

Works with the Reliability Test Laboratory to establish product qualifications including internal, military and customer test programs.

Works closely with the Customer Service Department to determine Customer quality requirements and to resolve Customer reported quality and service problems.

Bachelor’s degree in Business or related field and more than 7 years related experience.

Undergraduate degree or equivalent experience

Demonstrate understanding of managedcare entities (e.g., ACO; PPO; HMO)

CLM_Demonstrate Knowledge of Internal Business Operations

Accountable business owner for Quality initiatives for our 37K Value Based patients

Owns the end-to-end process to drive Quality for our patients and our organization

Driving, implementing, and leading Quality strategies to achieve expected outcomes

Over 10 years' experience in Quality in a Pharma manufacturing environment

Ideally with experience in finished product manufacturing

Leads the QA & QC departments with a staff of 20 and 2 direct reports

Responsible for directing and providing leadership for the implementation of global standards and procedures

Bachelor's degree in a Science related subject

Deep knowledge of Quality Systems Management

5+ years in a leadership or management position

Establishes and implements quality systems, programs, policies, processes, procedures, and controls according to established standards and regulatory requirements.

Ensures quality oversight across the organization by balancing risk-based approaches with compliance and phase-appropriate development capabilities.

Develop, implement, and manage a risk-based quality governance and oversight program in compliance with cGXP quality systems.

Establish internal and/or external QC testing capabilities to support in-process, release, and stability testing programs.

Develop, implement, and manage the quality management, policies and procedures, processes, and forms to ensure the achievement of quality targets

Regularly report status to the President and management team

Collects and provides monthly performance metrics to top management

Experience with AS9100 requirements within a Defense / Space / Aerospace manufacturing environment: mechanical / structures / airframes / machining etc.

Respect for People: Appreciates and leverages diversity in experience, heritage, education, organization level and gender.

Manages QC inspectors for incoming, in-process, and final inspections

Acts as the Quality Management Representative for regulatory authorities

May perform additional duties as assigned or directed by management from time to time.

Bachelor’s degree in life science or related field or the equivalent combination of education and/or experience. Engineering degree preferred.

Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management.

Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.

Manages product recall activities to include recall policies and procedures for the company.

Deep knowledge and understanding of GxP and regulatory requirements

Manage and provide leadership to Quality team members including on Quality Assurance, Quality Systems, and Quality Control.

Experience with operational process improvement initiatives

Excellent foundational skills including strong analytical, written and verbal communication skills, compelling facilitation and presentation skills.

Annual L&D stipend for conferences, continuing education, etc.

In return, we offer a supportive environment. We value: