Associate Director, QMC

• Consistently deliver high-quality services to our clients in the QMC areas (including Auditing, Quality Systems and Compliance, and expert Technical Consulting and Training) by managing, implementing and/or successfully executing projects, including timeliness, compliance with applicable standards, training and coaching staff, and adjustment of services delivery as approved by management or client when required
• When managing a team, oversee the project delivery team and consultants. Responsibilities include:
  • Project scoping, delivery, technical and budgetary activities
  • Ensure delivery is in line with project commitments and client requirements
  • Engage in recruitment activities of employees and consultants
  • Work hands on with clients as necessary to manage and/or execute projects with the goal of achieving on-schedule and on-budget projects, as well as a high level of client satisfaction

• Serve as a technical and QMC expert representative across teams and clients
• Be seen as a leader by clients, be sought out by senior management for any issues on project. Develop confidence of client as an industry expert
• Work hands on with clients as necessary to resolve issues, provide recommendations, and help implement solution
• Understand where client projects are regarding budget, and anticipate and communicate change orders which may be needed to resolve any overages
• Show agility in reducing client/vendor frustrations during project challenges
• Maintain constant contact with client and respond to their requests in a timely manner
• Challenge strongly held client assumptions, when appropriate
• Maintain meaningful relationships with clients after project is completed
• Keep abreast of industry technical and regulatory requirements

• Support the screening and conduct interviews of resources, focused on both technical knowledge and cultural fit
• Provide appropriate structure for team, with development opportunities for staff in both competencies and job specific responsibility
• Acknowledge performance issues with members of your team and address in a timely manner, provide timely and constructive feedback to team members unprompted
• Recommend talent management actions/decisions to ensure resources act in alignment to company strategies and goals, and client terms and conditions.
• Actively manage utilization of staff to expected levels; communicate when additional work is needed for staff or needs to be offloaded to another resource
• Proactively communicate and engage with corresponding area when additional resources are needed to support upcoming deliverables or projects
• Provide technical and regulatory direction to resources as required
• Train, develop and coach employees

• Identify opportunities for additional work within current projects, to include QMC services and the broader PharmaLex service portfolio
• Identify leads and opportunities within clients outside of current project scope, include sales staff as appropriate to help discuss and scope those opportunities and turn them into proposals for new work
• Actively seek out new client relationships and new business opportunities on behalf of PharmaLex
• Partner with BD team on scoping calls and development of proposals
• Attend trade shows and other events to represent PharmaLex
• Provide input on service/ product development opportunities.
• Follow-up with existing clients and potential new clients to increase the client base and increase sales
• Develop articles with technical content

• Keep abreast of changing regulatory standards, industry best practice and emerging trends to ensure competency of relevant personnel and consultant panel (as required and appropriate)
• Undertake own ongoing Continuing Professional Development (CPD) to ensure currency of technical knowledge and skills
• Promote and coordinate technical knowledge harvesting within the organization
• Develop, track and identifies new opportunities to improve company’s processes, and services and training offerings
• Build senior level relationships within client portfolio

• Ensure compliance with all PharmaLex company policies and procedures, including Quality Systems.
• Ensure all documentation prepared is in line with standards as set down by relevant legal and regulatory bodies

• Provide project status updates to key stakeholders as required
• Provide input to management on customer’s input, reaction or trends that may help company adjustment on services and project management cycle
• When assigned by Company, analyze complex issues, and significantly improve, change, or adapt existing processes or methods
• Collaborate with cross-functional teams within the Company and across clients’ sites
• Support the attainment of annual sales profitability targets
• Maintain frequent interaction with internal or external contacts at various organizational levels within the Company or clients’ sites concerning ongoing operations or changes relating to processes or programs. As QMC subject matter expert, leads briefings with internal and external contacts as needed

• Bachelors’ Degree in a scientific field and 10+ years’ experience; or equivalent combination of education and experience
• 10+ years of direct expertise working within the pharmaceutical, biotech, or medical device industry
• In-depth understanding of regulatory standards in pharmaceutical industry, and sources of regulatory information
• Ability to interpret complex regulatory guidance documents and apply their meaning to client development strategies
• Autonomous, concentrated and high-quality work
• Hands-on experience with quality management system (e.g., training, metrics, documentation management)
• Solid understanding of health care regulations
• Knowledge of ICH/GCP documentation requirements
• Knowledge of MS Office
• Knowledge of MS SharePoint
• Project Management skills
• Strong skills in the analysis and interpretation of results for projects of significant scope and complexity
• Ability to adapt under regularly changing conditions
• Very good command of English, written and verbal
• Outstanding organization, analytical, and problem-solving skills
• Excellent written, verbal and presentation communication skills

• Team members’ feedback
• Client Satisfaction
• Successful delivery of client programs – on milestone and on budget, or appropriate agreed deviations with client
• Financial performance of service area is within acceptable, agreed KPI’s

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.