PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management. 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 compliance challenges during the journey of bringing their products to market and helping them to maintain and sustain Quality Compliance level for products, processes and service providers, according to applicable regulations. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.
PharmaLex is proud to be an equal-opportunity employer. We respect and seek to empower each individual, and support the diverse cultures, perspectives, skills, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
As a Key Contributor You Will c onsistently deliver high-quality services to our clients in the QMC areas (including Auditing, Quality Systems and Compliance, and expert Technical Consulting) by managing, implementing and/or successfully executing projects.
You will provide Quality Compliance support as for a variety of projects. The individual will be responsible for developing, improving and advising on phase appropriate Quality processes and procedures in compliance with all current GMP and applicable global regulations and guidance. This role will also aid in assessing compliance level with current GMP requirements by performing audits, gap assessments and as requested aiding in remediation efforts for any gaps.
KEY RESPONSIBILITIES AND ACTIVITIES

• Engage with clients on scoping calls to aid with defining project needs.
• Execute Vendor, CMO, and Service provider audits on behalf of clients as needed in the area of expertise, write audit reports, and coordinate with clients on acceptable responses.
• Assist clients with the development of QMS and Quality Systems SOPs as needed based on the clinical or commercial phase of the product, example SOPs include: document control, batch record review and release, production oversight, investigations, CAPA, change control, complaints, recall, QMR, QRM, Training, vendor management, etc.
• Assist clients with ensuring robust investigations executed and CAPA/remediations assigned.
• As needed provide batch review and product release services for clients.
• Provide technical consulting as needed for client GXP concerns and formalize responses in writing within 1 week period.
• Assist with compliance gap assessments as needed including Annex 1 reviews and propose remediations for gaps found.
• Aid in assessing qualifications of additional consulting associates based on the project type needed.
• Participate in at least one Business Development event per year, including presentations, workshops, podcasts, and creation of published content.
• Assist with the creation of standardized tools to assist in the development of lean processes.
• Support assigned work activities for specific QA projects or objectives as required.

REQUIRED EDUCATION AND EXPERIENCE

• BA/BS in a Life Science or Chemistry field of study. Microbiology experience is a plus.
• Minimum of 10 years of experience within a Quality Assurance/Quality Operations role for Aseptic Production of sterile products within the Pharma Industry (e.g. Pharmaceuticals, Biotechnology, Medical Devices, Cell & Gene Therapy), within a global pharma company.
• 3 years of experience in a Quality Assurance/Quality Operations Manager role in Pharma industry.
• Knowledgeable of FDA, EMA, ICH, and other industry guidelines from major regulatory bodies as they relate to cGXP operations, and proven ability to relate these to current operations. Strong familiarity with Annex 1 is a plus.
• Familiarity with the latest industry practices from benchmarking groups such as ISPE and PDA.
• Knowledgeable about current global and regional trends in quality management and compliance across the product lifecycle.
• Demonstrated experience writing SOPs, Policies, and performing the entire Batch Record Review and Product Release process.
• Experience auditing (internal and external), writing audit reports and designing remediation plans that are fit for purpose related to business and resources.
• Hands-on experience with Quality Risk Management, execution of Risk Assessments and integrated Quality Systems.
• Experience working with third parties and effectively using strong interpersonal skills, and negotiation skills to influence and accomplish work.
• Experience with software related to Quality Management Systems ( eg. Veeva, Master Control, Trackwise, Documentum, ComplianceWire, etc.)
• The desire and ability to work in a fast-paced, start-up environment.
• Strong collaboration/teamwork skills, organizational skills, project management and attention to detail.
• Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders.
• Ability and skill to perform the detailed job requirements noted above competently, safely, and proficiently.

Key Performance Indicators

• Team members’ feedback
• Able to travel 25% - 30%
• Client Satisfaction
• Successful delivery of client programs – on time and budget, or appropriately agreed deviations with client
• Financial performance of service area is within acceptable, agreed KPI’s
• Utilization

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.

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