Director Of Quality Control Jobs

Responsible for oversight of contract QC laboratories including routine performance management and participating in audits to ensure sustained quality analytical deliverables.

Must have knowledge of cGMPs and biotechnology-derived product relations. Previous contract manufacturing facility experience is preferred.

Responsible for planning, scheduling and organizing QC activities related to meeting the compliance, supply, profit plan and strategy objectives of KBI.

Responsible for initiation and overseeing projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement.

Responsible for leadership of method validation of transferred methods.

Responsible for collaborating with cross-functional teams as the Quality Control Subject Matter Expert.

At least 3 years of management experience required

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

Oversee and conduct cGMP, ICH, and ISO stability programs to comply with regulatory requirements

Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees

Master's Degree in Chemistry or Chemical Engineering with a minimum of 5 years work experience in GMP manufacturing required or

Bachelor's Degree in Chemistry or Chemical Engineering with a minimum of 8 years work experience in GMP manufacturing required

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

Analytical and critical thinking skills to include: software systems, workflows (pharmacy, in-clinic, manufacturing), organizational knowledge including applicable industry requirements.

Certifications related to Quality Management Systems (ISO 9001, AS9100, etc.)

Oversees the competency requirements & certification programs for Trainers & Subject Matter Experts administering training within the organization

Manages Quality Assurance & Control staff & budget to meet business performance & cost measures

Identifies, monitors & improves Key Performance Indicators (KPIs) related to training & education programs.

5+ years industry experience in a highly regulated industry

PhD with 10 years’ experience in the sciences or equivalent education and work history.

Strong leadership skills with experience in managing diverse groups/teams

Manage assigned staff in accordance with company policies and procedures

Strong background in analytical chemistry with experience in cGMP

Coordinate improvement within the Quality Control department to optimize methods and processes

Establish metrics and KPIs to drive OpEx performance and operational efficiencies within the QC group

A minimum of 2 years of management experience including leading, motivating, and developing technical staff.

Developing and implementing learning and development opportunities for team members to enhance their skills and abilities.

Ensuring that development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.

Taking ownership of multidepartment projects (identifying tasks, assigning responsibilities and timelines, and ensuring timely completion of projects).

Develops, revises and reviews investigations, SOPs, qualification/validation protocols and reports

Manage QC files and Environmental Monitoring electronic databases.

Develop customer relationships both at the project level and management level.

Develop new Quality requirements to meet N/E goals.

Knowledgeable about heavy fabrication, welding, NDE, inspection.

Knowledge of ASME and AWS specifications.

Good communication skills, both verbal and written.

Good analytical thinking ability and problem resolution skills.

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 project management skills, with the ability to manage multiple projects and initiatives simultaneously.

• Collaborate with internal team members in Supply Chain Management, Production, and Merchandising.

• Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.

• Conduct regular audits of manufacturing partners and implement corrective actions to address quality issues.

• Perform other duties as assigned.

• GIA Graduate Diamond Diploma required.

Excellent verbal and written communication skills with the ability to train staff.

Excellent organizational skills and attention to detail.

Strong analytical and problem-solving skills.

Strong supervisory and leadership skills.

15-20 years’ relevant work experience, with 5+ years of supervisory experience.

Thorough understanding of quality control standards and methodologies.

5+ years of people management experience with proficiency in establishing objectives, monitoring performance, providing feedback, and developing staff.

Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.

Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines.

Manage Quality Control Microbiology staff including recruiting, onboarding, and performance management.

Escalate challenges to management; develop constructive proposals and implement solutions for resolution of challenges.

Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial and regulatory requirements.

Excellent leadership and management skills, with the ability to motivate and guide teams to achieve high levels of performance.

Strong project management skills, with the ability to manage multiple projects and initiatives simultaneously.

Create and drive KPI’s for QC department to ensure time management, quality, and customer satisfaction are met.

Collaborate with internal team members in Supply Chain Management, Production, and Merchandising.

Manage the quality control teams and implement and propose new corrective actions to improve the quality of product.

Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.

Be visible at the broker and state offices, meeting with sales representatives and management to ensure share of mind

Review programs and execution updates with broker management

Good managerial and effective presentation skills

Emphasis in Management and/or Marketing

2 years+ experience managing multiple control markets, experience in Canada preferred, but not required

Five plus (5+) years’ work-related experience in distilled spirits/wine supplier industry

Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment

Establish a lab operation compliant with Lilly Global Quality Standards and regulatory requirements, including establishing lab practices, procedures, test methods, etc.

Bachelor of Science in Biology/Microbiology or related work experience

Minimum 5 years of pharmaceutical leadership experience including leading or working effectively with a cross functional groups

Minimum 5 years GMP lab experience including microbiological testing, environmental monitoring, and method transfer

Deep understanding of compliance requirements and regulatory expectations

6+ years of experience leading a curation QC or Data Quality team with experience in the project management discipline.

6+ Information Governance, Data Management, DQ Experience.

Data curation control staff (global) team management; capacity planning; profile specifications.

Lead data cuts certification process design/ implementation/oversee.

Define requirements for a QC monitoring dashboard.

Develop QC standards in accordance with industry best practices and compliance /regulation requirements.

At least 3 years management experience required

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

Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements

Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees

Master's Degree in Chemistry or Chemical Engineering with a minimum of 5 years’ work experience in GMP manufacturing required or

Bachelor's Degree in Chemistry or Chemical Engineering with a minimum of 8 years’ work experience in GMP manufacturing required

Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL, etc.

Highly organized, detail-oriented, capable of multi-tasking, strong interpersonal skills in order to collaborate with individuals in a matrix environment.

Strong knowledge of QC testing of small molecule drugs in a compliant cGMP setting.

10+ years of relevant experience in a cGMP pharmaceutical QC environment, or 8+ years with a Master’s degree.

Experience in a commercial environment highly desirable.

Starts at $199,000 and is commensurate with experience

Serves as a member of the management team in designing, implementing, and monitoring quality operations and compliance.

Collaborates with management and senior staff across functions and roles to draft acceptable quality standards.

Evaluates program operations from a strategic level to ensure that program meet quality, integrity, functionality, and other requirements.

License and Certifications - Required

License and Certifications - Preferred

Responsible for performance measurements and analytics, customer reporting.

Collaborates with management and senior staff across production departments and roles to draft acceptable quality standards.

Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.

Excellent verbal and written communication skills with the ability to train staff.

Excellent organizational skills and attention to detail.

Strong analytical and problem solving skills.

Strong supervisory and leadership skills.