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Quality Assurance Manager

Location

Agawam, MA, USA

Department

Quality Assurance

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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 Manager of Quality Assurance supervises and coordinates the activities of assigned Quality area (i.e. Technical Review, Compliance ) and provides technical leadership for the assigned team. The  Manager ensures all QA activities are in compliance with company SOPs, GMP standards and FDA/EU and ISO 17025 regulations. This role will interact with clients and is responsible for successfully meeting client and departmental  objectives in a timely manner.

Responsibilities

  • Ensure compliance for all QA activities by working with external groups, labs, and vendors to ensure  timely testing and compliant documentation in support of material and product
  • Supervises the day to day operations for assigned area.
  • Ensures all staff members are fully trained.
  • Participates in and supports client visits, audits and inquiries to ensure complete fulfillment of requests and interests.
  • Recruits, trains, develops and retains staff for the effective process of departmental operations.
  • Provides technical guidance for troubleshooting and investigating simple to moderately 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.
  • Enforces all laboratory safety, security and housekeeping policies and procedures.
  • Actively contributes to the preparation and coordination of internal audits and regulatory inspections.
  • Creates strong and effective relationships with clients.
  • Maintains a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses.

Qualifications

  • Requires a life science degree and at least 4+ years of relevant QA/ Operations experience within the CDMO or Pharmaceutical And 6+ years in leadership roles.
  • Proven ability to work with site Quality and Operation teams to build and standardize quality  systems across sites.
  • Good analytical and problem-solving skills, with the ability to think strategically.
  • Strong attention to detail, as well as time and resource management.
  • Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
  • Promote a safe environment for work.
  • Comply with the general policy of the company.
  • Communicate well orally both for Internal customers and team members and external customers
  • Ability to write reports and business correspondences
  • Ability to listen and respond well to external customers, partners and colleagues at all
  • Staff may include salaried and/or hourly non-exempt employees. Expected to coach, train and develop skills of the subordinate staff.
  • Good team and interpersonal skills
  • Understands how to prioritize tasks according to business objectives and can pursue several objectives simultaneously.
  • Tackles problems with enthusiasm and curiosity.
  • Ability to listen and respond well to external customers, partners and colleagues at all levels.
  • Highly effective team and interpersonal skills with the ability to work across numerous management disciplines.
  • Highly goal and result oriented.
  • Can work independently with a high degree of self-motivation.
  • Treats colleagues at all levels with respect.
  • Very effective listening skills with the ability to hear attentively and process information correctly.