Job Overview The Director, Quality and Regulatory Compliance will support regulatory activities related to Chemistry and Manufacturing (CMC) as well as the release processes for the Cambrex Charles City facility. As a member of the site leadership team, this role will provide regulatory strategy, direction, support and advice for our CDMO organization. The Director, Quality and Regulatory Compliance will be responsible for engaging with internal and external stakeholders including clients and regulatory agencies. Responsibilities + Responsible for providing leadership and functional management to 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 international regulatory agencies regulations and expectations. Interface directly with agencies, other regulatory authorities and customer clients to ensure the company is appropriately represented in all matters related to compliance and quality. + Direct and oversee the quality planning and execution processes. + Develop short and long-term plans to achieve both quality and business objectives for the organization. + Develop the quality policies strategy and ensure that the quality policies and objectives are clearly communicated, implemented, and maintained within the organization. + Ensure development, manufacturing, testing and release, and distribution of products are consistent and meet all relevant regulatory requirements including federal, state, and international regulations, applicable standards and regulatory guidance. + Develop quality metrics and indicators to proactively identify and address quality systems or product-related issues. + Establish and lead a Quality Management Review (QMR) process to ensure continued compliance with CGMP standards. + Provide development and coaching to Quality and Regulatory leadership and their teams, emulating the company mission and values. 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. Qualifications/Skills + Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills + Ability to function as technical expert/consultant. + Ability to coach and develop staff and to transfer job knowledge and skills. + Strong interpersonal and leadership skills, including initiative and strong work ethic. Education, Experience & Licensing Requirements + Bachelor’s degree in chemistry, math or related scientific field (or closely related discipline). + 10+ years relevant work experience in CGMP/QA/QC/regulatory compliant pharmaceutical environment with a preference for CDMO API specific experience. + Knowledge of GMP manufacturing and analytical techniques to support QA and QC processes. + Expertise in creating and interpreting SOPs and driving action. + Track record of successfully applying high level scientific judgment in a variety of complex and unprecedented situations. + Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results. 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.