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Head of Quality

1 week ago

Charles City, Iowa, United States Cambrex Corporation Full time
Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
  • engage in work that matters to our customers and the patients they serve
  • learn new skills and enjoy new experiences in an engaging and safe environment
  • strengthen connections with coworkers and the community
We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today

Job Overview

The Head of Quality and Regulatory position at the Charles City site is responsible for site quality and regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) as well as site product disposition processes. As a member of the Charles City site leadership team, this role provides quality and regulatory strategy, direction, and guidance for the site. The Head of Quality and Regulatory position is also responsible for engaging with clients and regulatory agencies as applicable to assure site quality and regulatory compliance.

Responsibilities
  • Responsible for providing site leadership and functional management to site Quality Assurance, Quality Control, and Regulatory teams and ensuring adherence to current Good Manufacturing Practices (cGMPs).
  • Establish quality strategies to ensure cGMP compliance with US FDA, EMA, and other health authority regulations and expectations. Interface directly with regulatory authorities and clients as applicable to ensure site regulatory compliance and quality.
  • Direct and oversee site quality development and related execution processes.
  • Develop short and long-term plans to achieve both quality and business objectives for the site.
  • Develop site quality policies, procedures, and strategy to ensure that site quality objectives are clearly communicated, implemented, and maintained within the organization.
  • Ensure development, manufacturing, testing, disposition, and distribution of products are consistent and meet all relevant regulatory requirements including federal, state, and international regulations, applicable standards, and regulatory guidance.
  • Develop site quality metrics to proactively improve quality systems and resolve quality issues.
  • Establish and lead a Quality Management Review (QMR) process to ensure continued site compliance with cGMP standards.
  • Lead development and coaching of site quality and regulatory personnel consistent with the company's mission and values.
All employees are required to adhere to FDA, cGMP, DEA, and EPA regulations as they relate to site operations, and to adhere to all applicable safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties not described here relating to departmental mission and site objectives may also be assigned as applicable.

Qualifications/Skills
  • Excellent verbal and written communication skills, problem-solving, and organizational skills.
  • Ability to function as technical expert and consultant within the site with respect to quality and regulatory compliance.
  • Ability to coach and develop staff, and to transfer job knowledge and skills to the organization.
  • Strong interpersonal and leadership skills with ability to take initiative with strong work ethic.
Education, Experience & Licensing Requirements
  • Bachelor's degree in chemistry, math, or related scientific field (or closely related discipline).
  • 12+ years of relevant work experience in cGMP/QA/QC/regulatory-compliant, pharmaceutical industry with a preference for CDMO, API-specific experience.
  • At least 5 years of experience in leadership role directly supervising staff, preferably in pharmaceutical or biotech industry.
  • Expertise in creating and developing best practices and procedures while driving action.
  • Track record of successfully applying high-level, scientific judgment in a variety of complex and unprecedented situations.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' Relocation assistance will be offered for this position.

#LI-RD1

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.