Qualification / Validation Director

PharmaLex is now part of Cencora. We are one of the largest providers of Development Consulting & Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech, and MedTech industries, helping them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch. We have extensive regulatory and scientific experience in all therapeutic areas and product formulations.

As a Key Contributor you will consistently deliver high-quality services to our clients in the QMC areas (including Auditing, Quality Systems and Compliance, Commissioning Qualification and Validation, and expert Technical Consulting and Training) by managing, implementing and/or successfully executing projects.

This role will also work closely with internal consultants to implement strategies with multiple clients and ensure the consistent delivery of high-quality services. In addition, the Validation Director is expected to support internal programs including Finance & Accounting, Marketing, Business Development, Project Management, and Quality. The Qualification / Validation Director will support internal projects by developing skills across the following criteria: Project Management, Technical Expertise in the Service to be delivered to the client, Industry Knowledge, Written and Oral Communication, Client Management, Financial Management, and Business Development.

Key Responsibilities and Activities

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

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

Maintain meaningful relationships with clients after project is completed

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

Partner with BD team on scoping calls and development of proposals

Attend trade shows and other events to represent Cencora

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)

Required Education, Experience, Skills and Competencies

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

Strong experience of Commissioning, Qualification and Validation

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

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

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

For details, visit

Schedule

Full time

Affiliated Companies

Affiliated Companies: Pharmalex

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned