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Associate Director, QA Compliance and Operations

Location

Whippany, NJ, 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, 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.

The Associate Director Quality Compliance is responsible for promoting compliance and a continuous improvement culture to drive process and cost improvement; performing vendor / supplier audits and audit risk assessments to evaluate the compliance impact of new suppliers. This position will interact with various departments to critically evaluate quality systems in order to support process improvements  The Associate Director Quality Compliance is responsible for internal, customer, regulatory and vendor audits.  

Responsibilities:

Evaluate quality system processes recommend improvements in compliance with regulatory requirements.
Plans, organizes, implements and supports team centered continuous improvement activities.
Engage and align with other diverse and dispersed organizations and functions, building teamwork.
Partners with others and leads and motivates an organization in driving continuous improvement and change, improving customer satisfaction.
Responsible for handling on-site audits by domestic and international regulatory authorities This may include oversight of the “War Room” for document staging, preparation, pre-review and discussion with appropriate Subject Matter Experts (SMEs); directing Document Control Group in reediness and response. 
Generate response to audit observations, as well as tracking, driving, and reporting the status of committed deliverables.
Provides inspection readiness support to the site -identification of compliance gaps and risks, and participation in the remediation process.
Participate in inspection preparation, and participate in regulatory inspections, defending Deviation/CAPA policies and practices.
Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis.
Develop Deviation/CAPA policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems related to Deviation/CAPAs. 
Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
Manage product complaints for commercial and clinical investigational products.
Interaction with customers through management during complaint process and audits.
Identify gaps in complaint handling /deviation /CAPA process as it relates to reporting, metric, and trending to maintain seamless compliance and develop feasible plans for correction.
Oversee Annual Product Reviews program.
Possesses regulatory and business knowledge to champion improvements to the quality systems.
Integrate risk management with current and emerging processes.
Author and/or review and implement SOPs to ensure compliance with current Cambrex standards and cGMP
Other duties as assigned.

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.
May be required to wear personal protective equipment
Must be able to move about the facility
Must be able to remain sedentary for periods of time
Bachelor’s degree (B.S.) in engineering or sciences preferred.
10+ years related experience and/or training; Experience in managing people.  Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable.
People management experience necessary