Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.
This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.
This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.
The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities
- Plan, conduct, report and follow up contracted audits within agreed budget and timelines
- Conduct technical peer reviews and provide feedback on client deliverables
- Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
- Provide strategic advice to clients on Quality Management System development and change
- Provide a consultancy service for GCP and/or additional regulations
- Develop and deliver training programs and/or materials
- Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
- Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
- Foster and maintain good, professional working relationships with clients and identify new business opportunities
- Assist with the preparation of proposals and presentations to prospective clients
- Thorough knowledge of GCP and/or other applicable regulatory requirements
- Excellent attention to detail, organisation, and prioritisation skills
- Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
- Self-motivation and ability to function independently and within a team
- Ability to function calmly under pressure
- Practical and enquiring approach to problem-solving
- Dedication to quality and reliability in all aspects of work
- Responsiveness to customer needs and focus on customer satisfaction
This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.
We are recruiting on behalf of our client, a leader in the pharmaceutical company a Global Community Engagement Lead, available as soon as possible.
Relevant degree, postgraduate and working qualifications preferred in the relevant business or applied behavioral sciences (e.g. Strategy, Business Administration, Leadership Development, Psychology, HRM, MBB, etc).
Fluent in English
• Minimum 5 years LD, P&O or large-scale Project Management experience in a highly collaborative and matrixed environment.
• Strong experience with operational management of complex projects, stakeholder engagement, communication and relationship building skills.
• Proven analytical and conceptual skills, combined with ability to implement.
• Experience & comfort with technology for collaboration, including SharePoint (use and administration), MS Teams, Yammer.
• Ability to work within ambiguity and be flexible and adaptable to changing requirements.
• Demonstrated systems & strategic thinking, including the ability to look across the system, understand changing dynamics and evolve / develop plans accordingly.
• Known for strong collaboration and networking with the broader P&O community and other stakeholders.
• External consulting and/or business leadership experience would be valuable.
• Strategic and analytical thinking to understand, diagnose and solve complex business problems using systems lens on issues.
• Strong relationship management skills with experience in building trust and managing stakeholder relationships in a highly matrixed environment.
• Ability to adapt and be flexible, comfort with operating in an ambiguous environment and challenging status quo as appropriate. Ability to assess changing situations and adapt accordingly.
• High level project / program management skills and a high degree of organization and effective self-management.
• Strong team player with excellent communication skills. Desire and ability to coach and mentor others.
• Proven business understanding, combined with drive to drive implementation.
• Role modeling our aspired culture of Curiosity, Inspire and Unboss.
Specific Professional Competencies
• Experience in leading large scale, complex LD/ change management interventions or business improvement projects.
• Experience with and understanding of social leadership and the emerging / changing organizational dynamics.
• Proven collaborator and communicator.
• Experience supporting Leaders and Associates in their own personal developmental journeys, understanding of and empathy for the challenges that lie within this.
This is a 1-year contract.
Contractor Rate: CHF 59.14 – 66.53 per hour
If you are interested I would be happy to receive your application at:
Michael Parker at Skills Alliance has exclusively partnered on a retained search for an with an exciting Cell Gene Therapy company. They are looking for an experience regulatory candidate who specifically has experience working with the FDA. The role can sit at either AD or Director level and will be the most senior Regulatory person in the business.
The client are doing extremely well with a healthy pipeline as they approach late phase clinical they are now looking to bring RA in house. They have a head office in Oxford, UK and a new office in Boston MA. They are happy for this person to be based remotely with trips into to either office.
For this role it is imperative that you have lead and submitted applications for the FDA.
I have provided further details below for this particular role below. However if you are interested in going through the 4full details on this role or one of the 3 other senior Reg roles we currently have please get in touch as soon as possible.
Please note this role is also only available for candidates who are eligible to work and live in the UK or USA without sponsorship or a visaJob description
- Primary responsibilities include planning, preparation, submission and maintenance of IND’s and CTA’s in USA and EU, and liaison role with CRO’s
- Regulatory affairs activities and deliverables include providing strategic, technical and regulatory input for medical products (drugs products and medical devices), CMC for the development of human medicinal products, GMP manufacturing of both drug products and devices, clinical development, regulatory filings.
- Technical authorship of Clinical Trial Applications, INDs, Marketing Authorisation Applications, New Drug Applications, Scientific Advice and Meeting Briefing Documents
- Planning and execution of launch and commercialization activities and support for commercial/marketing, market access, PV, compliance and quality/supply chain throughout the product lifecycle
- Filing and review of US-FDA/EMA/NCA applications for the New drug products and Medical devices
- Communicate and liaise with regulatory agencies as needed to support the development of the regulatory submissions and Educate internal stakeholders on current regulatory trends and expectations.
- Collaborate across functions and find the balance between quality/regulatory standards and start-up agility
Education and Technical Experience
- MS, PhD in Pharmacy, Chemistry, Biochemistry, or Pharmacology, or a related scientific discipline or equivalent combined education and experience.
- In-depth knowledge of 21 CFR 210/211, Eudralex EU GMP, 21 CFR part 820, 21 CFR part 312, 21 CFR part 316, ISO 13485, MDR and other international regulations and standards for both drug products and medical devices.
- Experience in preparation of IND and CTA applications for drug products required, preferably experience weighted toward US-FDA. Experience in writing Technical Files and 510(k) or PMA applications for medical devices is an advantage.
- Clinical development and/or pharmaceutical industries experience required.
- Approximately ten years of regulatory affairs experience with both drug products and medical devices, with experience in ophthalmology as a preference. Experience in clinical study design and with combination drug-device products is an advantage.
- Experience in interactions with health authorities and hands-on experience managing regulatory programs from product development through clinical development and the approval process.
- Experience in regulatory support of drug development, including clinical product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development. Preference for candidates with significant experience in drug development for the United States and Europe. Exposure to development of new chemical entities is an advantage.
- Preferably, experience in medical product start-up/fast growth company or similar working environment. Willing to go the extra mile. RAC/TOPRA accreditation is an advantage.
Please get in touch as soon as possible for full details.