Quality Assurance Director

Company: Cambrex Corporation
Location: Longmont
Posted on: February 22, 2021

Job Description:

At Cambrex, it's our people that set us apart. We work locally and have an impact globally. We're committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal - to improve the quality of life for our customers' patients across the world. Overview The Director of Quality leads and mentors the quality team and is expected to be an integral part of the site leadership team. This role will interact with clients and is responsible for successfully meeting client and departmental objectives and metrics in a timely manner. The Director of Quality is responsible for the quality and compliance of the assigned site and maintains the data review through issuance of data and final report. This role is responsible to manage and--coordinate the activities of assigned team. Staff may include salaried and/or hourly non-exempt employees. The Director is expected to coach, train and develop skills of the subordinate staff. Responsibilities

• Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals
• Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer
• Manages the day to day operations for assigned area.
• Ensures all staff members are fully trained.
• Directs, participates in and supports client visits, client audits, regulatory audits and inquiries to ensure complete fulfillment of requests and interests.
• Oversees the good documentation practices and data integrity to assure review and approval of Protocols, IO/PQ and Investigations.
• Implements measures and processes to ensure assigned site is compliant to and oversees registration and surveillance audits.
• Evaluates processes and process improvement initiatives.
• Facilities the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site's needs.
• Recruits, trains, develops and retains staff for the effective process of departmental operations.
• Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
• Applies statistical analysis for interpretation of project data.
• Ensures all CGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
• Effectively resolves quality issues and concerns in a timely manner.
• Creates strong and effective relationships with clients.
• Effectively manages the processes for internal audits, client audits and regulatory audits.
• Effectively oversees the good documentation practices and data integrity to assure review and approval of Protocols, IO/PQ and Investigations.
• Evaluates processes and process improvement initiatives. Qualifications
  • BS or BA Degree with 10+ years or MS Degree with 8+ years or equivalent.
  • At least 6 years of experience in management roles directly supervision staff.
  • Industry experience must be with Quality Assurance Systems in a contract lab environment.
  • Prior experience with strategic planning, building operations, or business operations is strongly preferred.
  • Experience managing GMP and GLP quality systems and quality policies preparation.
  • Extensive knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
  • Experience in quality systems, compliance and electronic Quality Management Systems.
  • Demonstrate the capability for continued upward growth and technical contributions.
  • Exceptional analytical and problem solving skills with the proven ability to think strategically.
  • Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
  • Excellent diplomatic, analytical, and communication skills - both verbal and written. Be the first to receive our latest news updates

Keywords: Cambrex Corporation, Longmont , Quality Assurance Director, Executive , Longmont, Colorado