Senior Director Quality Assurance Jobs in Mills, Iowa

Proven background in GCP and GMP audit management, risk management, mitigation, and controls.

Job title is commensurate with experience and skills.

Develop and manage department budgets and long-range plans for the team

10+ years of relevant and current work experience in pharmaceutical QA/QC required.

Strong knowledge of biologics, gene and/or cell therapy manufacturing processes.

Hire, develop, and retain QA personnel to create a high-performing credible team.

Highly developed oral and written interpersonal, communication, negotiation and conflict management skills and the ability to work effectively with other people

Establishes quality and reliability standards by partnering with operations leadership, other members of management, and with production operators and analysts

Evaluates program operations from a strategic level to ensure that program meets quality, integrity, functionality, and outcome requirements

Calibrates with Learning & Development team to identify and deploy education and training opportunities aligned to identified trends for improvement

Completes quality assurance operational requirements by scheduling and assigning Quality Assurance Specialists workflows and following up on work results

Bachelor's degree, or 3-5 years of progressive leadership experience (required)

Bachelor's Degree in engineering, business, or construction management. Relevant work experience is also to be considered as an alternative.

Oversee the preparation and control of project-specific quality system management documentation prior to project commencement.

Manages quality assurance staff job results by coaching, counseling, and disciplining employees.

10+ years of construction QA/QC experience, preferably in solar, civil, or utility infrastructure projects

Assures quality products and processes by establishing and enforcing quality standards and testing procedures for materials and products.

Preparation of QA manual control and supervision of all amendments and revisions.

Prior management experience/Must have a demonstrated work history leading highly successful and motivated teams.

Experience in Pharmacy Business Management and/or Healthcare related fields a plus

Lead and coordinate quality assurance testing functions for Pharmacy Business Management across multiple functional areas, including Direct to Consumer platforms.

Should interact and collaborate with Innovation and Engineering team and report on high-level metrics for team management on status and progress.

Define department best practices, oversee personnel management, work with senior leadership on budget and hiring functions.

Participate in project requirement sessions, analyze and build test cases and prepare test plans

Advanced skills in Microsoft Office required and experience in using complex database systems

Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement

Bachelor’s degree or equivalent experience

Minimum 5 years’ experience in a quality assurance function

Minimum of 3 years' experience managing teams, either directly or indirectly

Strong analytical skills with demonstrated ability to synthesize complex or diverse information

Develop, implement, and maintain GMP quality management systems, policies, and SOP.

Identify compliance risks, perform risk management, and implement risk mitigation, as applicable.

Manage supply chain, logistics and return product disposition/destruction with 3PL.

Review and approve, audit agenda/reports, product specifications, test methods, qualification/validation protocols and

Experience working with CDMO/CMOs, vendors, and 3PL-supply chain/distribution of clinical products is a plus.

Manage GMP training and provide quality training as appropriate Perform other duties as required.

Experience performing, and advanced knowledge of, Quality Assurance and Project Management activities.

Experience with 508 compliance/accessibility requirements and testing.

Plan, manage, and track QA team work items.

Seven (7) years of experience in an IT QA role

Five (5) years of experience working with financial systems

Five (5) years of experience using SQL queries in business analysis and/or testing.

Experience of testing methods and knowledge of techniques (ISTQB certificate);

Commercial testing experience (4+ year);

Communicative English skills (B2 or more);

Good communication skills (verbal & written);

Experience of the scrum methodology.

Experience with working with JIRA, X-Ray;

Demonstrated audit conduct and management experience in GCP disciplines

Maintains knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organization

Equivalent combination of education and experience.

Manages and/or participates in audits and regulatory inspections;

Minimum 10 years of relevant experience in pharmaceutical/biotech

Minimum 6 years GCP Quality Assurance experience preferred

Knowledge of CLIA and CAP laboratory certification

Maintain and manage QA provided GLP/GCLP trainings

Manage GLP/GCLP CAPAs and Deviations

Conduct and manage internal GLP/GCLP process and systems audits

An understanding of and practical experience establishing and fostering compliance with GLP/GCLP regulations and guidelines

Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 5-10 years of experience

Support project planning and execution including scheduling, task management, milestone planning and reporting

Experience in quality roles preferred

Experience with cell and gene therapy products preferred

Experience in regulatory inspections, including dealing with compliance issues identified by regulatory authorities

Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines

Open, available, transparent communicator with strong leadership, presentation and influencing skills, and problem-solving ability

Demonstrated experience in Quality or Risk Management activities.

Expertise in Clinical Trial Risk Management

10 - 12 years’ experience in clinical research and/or experience in ICH -GxP principles

Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred

Expertise in root cause methodologies (e.g. 5-whys, fishbone diagram, etc.) and CAPA development

Expertise with ICH-GxP principles and clinical trial or non-clinical trial regulations as applicable

Assists in the management of external audits by regulatory agencies or external sponsors.

Develops organizational metrics of audit finding reports for management as requested.

Prior experience within academic research, sponsor, or CRO settings (Clinical Research Associate, Clinical Trial Managers, CRAs, CRCs or Clinical Trial Assistants).

The University also offers a comprehensive benefits package that includes:

BA/BS degree and at least six years of relevant experience.

Quality auditing or monitoring experience.

Manage quality systems, and inform senior leadership in compliance with quality system requirements

Participate with leadership in setting strategic direction and developing the capabilities of the QA/RA team

Bachelor's degree and 10+ years of related experience

Strong knowledge of quality and regulatory standards pertaining to surveillance testing, approved diagnostics, and sample collection kits

High level of knowledge of business operations, objectives and strategies

Excellent problem-solving and decision-making skills

Provides management with updates on CAPA completion status and produces metrics for quality oversight committees and senior management.

Responsible for initial and re-qualification of PV service providers as well as other GxP service providers that touch Pharmacovigilance.

Experience leading and facilitating inspection readiness activities and hosting or supporting FDA and other international regulatory agency inspections

Experience managing internal and contract personnel and external vendors and auditors

Lead and oversee the development, maintenance, execution, and completion of the PV Audit Program.

Reviews audit reports, evaluates the impact of audit findings and track audit actions to closure.

Experience with quality management systems (SQF, ISO, HACCP, GMP, etc.).

Embrace the opportunity to be a valued member of the management team and grow professionally as the company grows.

Contribute significantly to company goals through the support of a small, highly competent management team.

Bachelor's or Master's degree in Food Science, Food Technology, Microbiology, Quality Management, or related field.

Minimum of ten years of progressive experience in quality assurance and quality control within the food manufacturing industry.

Strong understanding of food safety regulations, standards, and compliance requirements.

2.2 At least 3 years management experience in a biotech industry

2.7 Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.

2.9 Strong interpersonal skills, with experience in leading high-performance team and cross functional projects.

1.7 Ensure the validation programs and SOPs are properly established and they meet regulatory requirements.

2.3 Experience in hosting FDA, EMA, and other regulatory agencies’ inspections

2.4 Experience in establishing and improving quality systems.

Participate in and provide QA direction in development program planning and management meetings.

Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.

BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience

Manage QA consultants and other external vendors, including organizing and prioritizing group tasks, performing training; expand QA department, as needed.

12+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Strong interpersonal, communication, teamwork, and analytical skills

Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.

Implemented or operated a quality program with an internationally recognized Quality Management System (ISO 9001, ISO 17025, and/or ISO 13485 standards)

Experience in FDA regulated manufacturing preferred.

Evaluates Quality Assurance staff performance accurately and fairly. Communicates and discusses performance on a regular basis. Prepares performance appraisals.

Identifies key development needs for staff and works to mentor staff and provide appropriate training and assignments in core competency areas.

Bachelor’s degree in chemistry, biology, or related field

A minimum of 10 years of experience in quality management within the electronics manufacturing industry.

Strong knowledge of quality management systems (e.g., ISO 9001, AS9100) and industry standards.

Certification in quality management (e.g., Six Sigma, Lean, or ASQ) is a plus.

Bachelor's degree in engineering, quality management, or a related field (Master's degree preferred).

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

Exceptional communication and interpersonal skills.

Collaborate with cross-functional teams, including development, product management, and customer support, to drive quality initiatives.

Present regular quality status reports to senior management, highlighting areas of concern and improvement opportunities.

Recruit, mentor, and manage a high-performing QA team, providing coaching and professional development opportunities.

Foster a collaborative and inclusive team environment that encourages open communication and knowledge sharing.

Experience with test automation tools and frameworks.

Excellent communication, leadership, and interpersonal skills.

Strong knowledge of quality management principles, methodologies, and frameworks (e.g., Six Sigma, Lean, ISO standards).

Guide the leadership team in the integration and management of a world class QMS for Pura products and processes.

Adept at communicating up. Communication skills coach for junior team members.

Strong problem-solving abilities, root cause analysis, and attention to detail.

Implement ISO 9000 (or equivalent QMS) companywide.

Develop and implement a quality production program to ensure conformity of purchased material and final products to quality standards.

Ensures adherence to change management process and support validation activities such as development of user requirements, protocols and reports.

Leads Quarterly Management Reviews with the executive team.

Ability to make risk-based and phase appropriate decisions and effectively communicate risks to management.

Leads internal audits, customer audits as well as surveillance and certification audits by our notified body to ensure compliance.

Strong verbal and written communication skills and ability to navigate stakeholders from various departments.

Requires knowledge of ISO 9001 and/or ISO 13485, 21 CFR 820, or ICH Q7.

Develop and maintain appropriate TMF management process.

Maintain expert knowledge in regulatory requirements including cGCP principles

Technical Skills Requirements / Core Competencies

Manage and/or deliver yearly cGCP training for staff.

Experience as an Auditor within the GCP area preferred.

Experience in Oncology is preferred.

Sekisui Diagnostics offers a competitive compensation.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

To be successful in this role

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

Knowledge of industry accreditation and ICF/IID standards as well as state licensure requirements and agency policies and procedures.

Coordinate annual review and update of agency policies and procedures to ensure compliance with all standards for accreditation, certification, and licensure.

Coordination of agency record-keeping systems to ensure compliance with all required accreditation, licensure, and certification standards.

Development and implementation of systems to assure compliance with licensing requirements.

Ability to plan, organize, implement and evaluate complex administrative responsibilities.

Support effective management of the QA process and related continuous improvements

12+ years of quality assurance experience

Proven leadership experience managing large, diverse global teams

BA/BS degree or equivalent work experience required

Financial acumen with experience managing own budget

Experience in a customer service environment or related position

UniSea offers a rich benefits package including:

Evaluate, mentor, and supervise departmental managers and supervisors.

Minimum of 6 to 9 years’ experience in seafood or other fisheries food quality assurance programs.

Excellent communication and organizational skills.

Hybrid work environment (2 days remote, 3 days in office)

Develop procedures, standards and guidelines for the QA department and their members to follow.

Knowledge of pharmaceutical industry and project management experience in leading cross-functional projects

5 or more years of professional development and / or management consulting experience

Continue to drive targeted role-based R&D GxP training deliverables and program management (e.g., bundling opportunities, high-risk training and understanding)

Lead planning and implementation of prioritized learning programs / initiatives inclusive of budget definition and management

Supports design, development and oversight of new learning management systems or system functionality

Provides matrix management and leadership to project teams

Advanced skills in Microsoft Office required and experience in using complex database systems

Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement

Bachelor’s degree or equivalent experience

Minimum 5 years’ experience in a quality assurance function

Minimum of 3 years' experience managing teams, either directly or indirectly

Strong analytical skills with demonstrated ability to synthesize complex or diverse information

5-10 years of experience in quality for HCT/Ps and/or medical devices

Bachelor’s Degree in a biological science or related field required

** Candidates MUST be US Citizen or Green Card Holder - No C2C or Sponsorship Available **

Recruit and manage a highly functional and motivated QA team.

BS or MS Degree in Computer Science, Information Science or related with equivalent experience

Experience leading quality and test engineering functions for large-scale products/services across server, web/SaaS, desktop, and mobile platforms

Experience with test automation and frameworks

Experience recruiting, leading and developing high-quality teams that produce results

Very strong communication skills, including an ability to communicate effectively to technical and non-technical stakeholders