**Cambrex** **Locations:** Whippany, New Jersey **Categories:** Quality Assurance **Req ID:** 2596 **Overview** The Associate Director, Quality Operations plans, coordinates, and directs quality assurance programs designed to ensure quality production and release of products consistent with established standards. This position manages the daily function of the QA Operations & Inspections, QA Document Control and QA Disposition. Supports the Business Unit by providing necessary data, writing reports, and conducting research on various topics. Stays updated on best practices and quality trends and regulatory requirements. **Responsibilities** - Ensures Six Sigma and Lean methodologies and tools are implemented and utilized to improve products and processes, resulting in reduced customer concerns and increased uptime.- Conducts audits of facilities to provide an independent source of compliance assessment to ensure customer satisfaction and conformance to operational procedures.- Creates and reports quality and performance metrics regarding customer concerns, internal quality issues, and procedural concerns for all locations within the company. Assists where needed with problem resolution and customer concern management.- Provides mentoring, coaching, and leadership to facility managers and regional leadership for resolution of production quality issues and customer complaints and improvement in operational metrics along with ensuring personnel development and growth.- Partners with Operations, Manufacturing, Packaging, QC, Facilities, Technical Services and Validation to resolve quality issues on the shop floor.- Oversees and maintains Quality Assurance Inspection, Document Control, Batch and Material Disposition Programs to ensure appropriate quality and compliance.- Provides direction, development, and leadership of staff. Establish realistic goals and objectives. - Plans and directs work activities, and monitor progress such that goals and objectives are accomplished efficiently, completely, and within established timeframes.- Ensures appropriate sampling and disposition of raw materials, intermediates, packaging, labeling and finished drug/drug products. Provide daily oversight to QA Inspections and Batch Release performing:- Sampling and inspection of API, raw materials, labeling/packaging components and drug products.- In-process product audits (packaging, PD, and manufacturing).- Release/rejection of materials/drug products in computerized inventory system.- Processing of notices of rejection- Review and approval of cGMP documentation- Review and release of intermediate and finished drug product- Provides QA support of GMP investigations and associated CAPAs.- Authors, reviews and approve SOPs related to operational activities. - Maintains communication and collaboration with Customers and internal groups such as Production, Supply Chain and Project Management.- Evaluates current quality systems and propose process improvements to reduce non value added activities. - Reviews and approves GMP documentation related to QA Operations, Production & Process Controls, Facility & Equipment Controls, and Laboratory Controls, QA Product Disposition (i.e., SOPs, validation protocols, qualifications, specifications, master batch records).- Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation. - Provides support during regulatory inspections and client audits.- Provides inspection readiness support to the site -identification of compliance gaps and risks, and participation in the remediation process.- Performs investigations for quality related events. **Qualifications** Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide process improvements. Of particular importance understands quality systems. Possesses some knowledge of project management tools and has some experience leading cross functional teams.- Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.- Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.- Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals. Ability to prioritize and respond to changing business demands.- Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices. Strong problem solving skills and analytical assessment for continuous improvement.- Able to critically think, assess problems and collaborate to come to an appropriate resolution. Proactive and driver of continuous improvement operations. Applies risk management philosophy to business processes, decisions, and data- Innovation- Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. Applies risk management philosophy to business processes, decisions, and data- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.- Must be able to move about the facility- Must be able to remain sedentary for extended periods of time- May be required to wear personal protective equipment EDUCATION: - Bachelor's degree (B.S.) from four-year college or university in engineering or sciences.- Advanced degree highly preferred. EXPERIENCE:- 7+ years in a quality assurance operational role in a cGMP-regulated environment, with at least five (5) years in Quality Assurance Management.- Knowledge of products, equipment, processes, customer applications, quality systems, quality improvement tools, and problem-solving techniques.- Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable.- Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing.- Experience in non-sterile and sterile manufacturing and packaging environments.- Experience in quality engineering. - Knowledge of aseptic operational practices.- Experience in small molecule.- Experience in leading investigationsCambrex 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. \#LH-SS1\#/CB !(https://analytics.click2apply.net/v/z1l7loidPkBMnCe7ns1xJ4) https://www.click2apply.net/z1l7loidPkBMnCe7ns1xJ4 PI181972758
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Enjoy working with our experts to accelerate your small molecule therapeutics into the market.