Quality Assurance Associate Manager

at  Fujifilm Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies :
We are different. We strive for better. Our people never settle for the status quo and as you push the boundaries of your potential, you not only change your life, you change others’ too.
We are looking for people who share our passion, drive, and energy – what we call Genki. Join us as a Associate Manager in the Quality Assurance team, and commit your life’s work to impacting where it matters most: human lives.
About Us:
We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.
With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.
Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.

Role & Responsibilities:

• Manage the compliant delivery of designated elements of the business Sales and Operations Plan (S&OP)
• Build and maintain good working relationships with key stakeholder functions and any other departments/individuals as required
• Evaluation of recommendations and make final decisions, but where appropriate identify escalation requirements with further recommendation to senior management
• Identification, assessment and mitigation of risk with escalation of high residual risk
• Ensure self and team (including line reports) have no overdue training, or site actions. Support other QA teams and other functions within area of direct influence, in completion of site actions
• Manage, motivate, train, and coach, any direct reports to ensure assigned Quality Assurance (QA) and personnel development objectives are achieved within agreed time-scales. Identify potential candidates for succession plans
• Able to coach/train personnel of non-QA roles, in the application of GMP Principles including the underlying rational of those principles
• Demonstrate Subject Matter Expertise (SME) in more than one QA System

Qualifications and Experience:

• Chemistry/Microbiology/Biochemistry degree or a related subject or equivalent experienceX Application form/Certificate
• A minimum of 5 years’ experience in a GMP/GLP environment
• Applied Knowledge and proficiency of QA systems: (for example Events/Deviations, CAPA’s, change control)
• Demonstrate a sound knowledge of how the principles and practices of GMP are applied to areas of responsibility
• Demonstrate capability to deliver change and continuous improvement objectives
• Experience in line management
• Ability to plan effectively over a period of up to 12 months

Why work with us?:
At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.

When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer:

• Competitive salary plus company bonus scheme
• 35 days of holiday, plus bank holidays.
• Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
• Generous pension scheme
• Free parking and electric charging points

• Manage the compliant delivery of designated elements of the business Sales and Operations Plan (S&OP)
• Build and maintain good working relationships with key stakeholder functions and any other departments/individuals as required
• Evaluation of recommendations and make final decisions, but where appropriate identify escalation requirements with further recommendation to senior management
• Identification, assessment and mitigation of risk with escalation of high residual risk
• Ensure self and team (including line reports) have no overdue training, or site actions. Support other QA teams and other functions within area of direct influence, in completion of site actions
• Manage, motivate, train, and coach, any direct reports to ensure assigned Quality Assurance (QA) and personnel development objectives are achieved within agreed time-scales. Identify potential candidates for succession plans
• Able to coach/train personnel of non-QA roles, in the application of GMP Principles including the underlying rational of those principles
• Demonstrate Subject Matter Expertise (SME) in more than one QA Syste