Associate Director, Global Pharmaceutical Quality Systems

Basildon, Essex

Hybrid working: 3 days office/2 days home per week

Competitive + Bonus + Benefits

If you are a high-performing quality manager with a proven track record of building a strong team where everyone reaches their potential, then we want to hear from you!

Join us to help improve peoples’ lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our Core Behaviours Are

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future – in our products, our brands, and our people.
• We give back to our communities.
  
  

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.

We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About The Role

This is a senior level role with responsibility for the management and compliance of the Global Pharmaceutical Quality System (PQS).

Reporting into the Director of Quality Operations you will be responsible for:

• Ensuring that the Global PQS is maintained.
• Periodic reviews of documentation, management reviews and self-inspections.
• Collaboration throughout Quality and other departments to ensure alignment and engagement between functions regarding the PQS.
• Hosting Regulatory Inspections and Customer/Partner Audits.
• Ensuring inspection report response and CAPA are created and approved
• Disseminating audit findings across the Pharmanovia group and coordinate gap assessment and resolution where observations may affect multiple entities.
• Ensuring that Complaints, Change Control, CAPA, Deviation, Self-Inspection, Recall, PQR, Training and Documentation processes are supported and governed by the PQS team.
• Reporting on PQS compliance status proactively highlighting issues and remediation plan requirements.
• Reviewing the training requirements for the PQS role(s) as per the Training procedure.
• Oversight of review and approval of internal deviation investigations to ensure appropriate CAPA are assigned and implemented.
• Ensure PQS governance processes (Management review, CCB, Complaints, PQS Clinics as necessary) occur and are successful.
• Oversight of design and approval of SOPs for PQS responsibilities.
• Ensuring an annual self-inspection schedule is created, approved, and executed.
• Supporting the design, effectiveness, validation status and management of the company EQMS.
• Training and development, goal setting, performs reviews and appraisals.
• Ensuring the PQS team acts in compliance with GMP, Health & Safety and internal standards and policies
• Designing leading and supporting continuous improvement projects across the department and company.
  
  

About You – What We Are Looking For

• Previous experience of working in a pharmaceutical company in a role with significant responsibility.
• Thorough experience and knowledge of the design and content of all aspects of a pharmaceutical quality system.
• An in-depth understanding of PQS design and remediation.
• Knowledge of Good Practice guidelines and relevant industry legislation/regulation.
• Natural leadership skills, proven skills in developing, supporting, and motivating a PQS team.
• Experienced in delivering presentations including working with data.
• Training and coaching skills.
• Ability to forge sound working relationships with others
• Strong academic background, degree/post graduate degree in pharmaceutical science or equivalent.
  
  

What We Offer

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards and social events.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.