Sr. Director, QA GCP

Copenhagen, Denmark

BRIEF COMPANY PROFILE
Our client was founded more than 25 years ago in Denmark as a biotech company with an exclusive focus on the design and development of innovative peptide-based medicines with an ambition of providing more safe and effective treatments in areas of high unmet medical needs. Celebrating more than 25 years of achievements, our client is a world leader in discovering and developing peptide therapeutics. The advanced peptide-based solutions and products aim to help thousands of people suffering from metabolic and gastrointestinal diseases. Since the foundation, the company's R&D has pioneered the peptide therapeutics area, resulting in two launched peptide-based products and a rich portfolio of active R&D projects. Our client is at the cutting edge of peptide analogs, with a strong scientific foundation, and has advanced more than ten novel peptide analogs into clinical development. The corporate strategy's refocusing has placed pipeline growth and scientific excellence at the highest priority, founded in strong commercial and strategic partnerships along the R&D value chain. With two products on the market and three candidates in late-stage development, our client is a success story in Danish biotech. Designing and engineering peptide analogs with enhanced biological activity, extended duration of action, and increased stability has been the driving formula for the success of our client. Why join our client? You will have huge impact on further strengthening the Quality and compliance platform of the company. You will take a seat on the QA leadership team where you can impact the strategic quality direction of the organization. You will enter a company with the 2^nd highest ranking employer brand in the Life Sciences industry in Denmark, and the #1 ranked employer brand in: Empowerment - taking part, as an employee, in key decision-making processes Compensation - being offered good remuneration (salary) terms and employee benefits You will enter a company with a Net Promoter Score of 57 (willingness to recommend Our client as an employees) from Employee Survey in September 2024 (DK average is 8, DK life science is 10-30). You will take part in building and expanding the QA GCP team, currently consisting of three (soon four) highly qualified and well-functioning specialists You will work in a highly successful and well-funded biotech company, less influenced by big corporate bureaucracy and with a rather flat organization with few layers. You will join a successful company working within one of the “hottest” therapeutic areas today. You will join a company with 2 rare disease products targeting devastating diseases.

THE POSITION
Reporting to the SVP, Quality, the Senior Director, QA GCP will take a seat on the QA leadership board while leading a team of 3 FTEs and Subject Matter Experts (will soon grow to 5 FTE’s). The position is responsible for the development and continuous improvement of robust Clinical Quality Management Systems (QMS) for pre- and post-market programs. Moreover, the Senior Director, QA GCP will be responsible for fostering Good Clinical Practice (GCP), Good Laboratory Practice and Good Vigilance Practice (GVP) at our client. This includes development of strategic audit plans while ensuring planning and effective conduct of audits, issuing audit reports, confirming suitability of corrective and preventive actions (CAPA), verifying and tracking CAPAs to completion, and keeping management informed of CAPA metrics. In addition, a key activity is to lead and help prepare for GCP/GLP/GVP regulatory inspections. Other responsibilities include provision of regulatory compliance and QA guidance to clinical, laboratory and drug safety teams while providing QA input into the clinical, laboratory and PV QMS related policies/procedures. The position as Senior Director, QA GCP at our client offers an exciting and challenging position in a highly collaborative, informal – though highly professional, dedicated and dynamic – organization with a high degree of interorganizational collaboration and focus on joint effort and commitment. The Senior Director is expected to set a clear direction and provide situational leadership of the QA GCP team. Hence, the role requires strong leadership capabilities of building and coaching a team of highly skilled specialists to successfully deliver on targets. The ideal candidate possesses a strategic mindset while being a true team player with a focus on creating an open, inclusive, and collaborative work environment and establishing transparency in the team. Additionally, the candidate must possess a solution-oriented mindset while ensuring a smooth cross-functional collaboration and interactions between the QA GCP areas and other departments within our client.

POSITION PROFILE
Position title:	Senior Director, QA GCP.

Reporting line:	Senior Vice President & Global Head of QA.

Reporting to the position:	3 FTE’s (1 under contract), will expectedly grow to 5 FTEs shortly.

Location:	Søborg.

Responsibilities	Professional Leadership Fostering compliance with GCP, GLP, GVP and Clinical Laboratories and oversight of respective QMS/SOPs. Maintaining high degree of knowledge of global industry expectations, GCP regulations and providing GCP expert support/guidance to staff in support of GCP operations. Interpreting GCP and GLP regulations and other external regulatory requirements and communicate to colleagues in our client’s organization to create solutions and reach a compliant level of operation. Acting as QA GCP advisor and reviewer of relevant clinical documents including but not limited to risk assessments and clinical protocols. Being the sparring partner and lighthouse of GCP and GLP compliance at our client. Resolve quality incidents jointly with head of quality and relevant line managers" Team Leadership Setting a clear direction and objectives for the team. Leading, motivating and engaging the QA GCP team. Ensuring continuous improvement and development of the QA GCP team to ensure a high level of effectiveness and execution power in the team. Securing a successful performance of the daily operation in the QA GCP department, including overall responsibility for GCP, GLP, GVP and CAPA. Managing time and resource planning for the team. Leading the QA GCP team/department to bring structure and facilitate cross-functional collaboration to ensure accountability and drive for results.

Tasks	Supporting and actively driving maintenance and further development of the Quality System within the GCP area, including but not limited to authoring and reviewing SOPs and hosting the GCP SOP Committee. QA Approver of Deviations, CAPAs and changes in the GCP and GLP area. Developing and planning the clinical and non-clinical QA training program, materials, and training classes in collaboration with internal departments. Being the driver in planning activities and preparations for Health Authority inspections. Planning, performing and following up on internal and external audits within GCP and GLP including but not limited to CROs and clinical sites audits while approving and coordinating with external audit consultants. Fostering compliance with a quality mindset in the QA department and in the Clinical Development area of our client. Handling of potential serious breach, fraud, and misconduct in Clinical Trials. Being the main contact on Compliance topics towards clinical and non-clinical CRO´s. Assisting the line departments providing GCP expertise during Vendor Selection and approve Vendor selection.

CANDIDATE PROFILE
Educational background:	Preferably M.Sc.-level degree e.g. in Engineering or other Scientific disciplines.

Language:	Fluency in English (verbally and written)

Ideal experience:	+10 years of experience in the biotech/pharmaceutical/ CRO industries, and in a Quality Assurance function. Proven leadership skills with a track record of building effective and coherent teams. Broad experience within GCP – and preferably also GLP and GVP. Demonstrated knowledge in the regulatory areas of importance to (e.g., FDA/EU Regulations, 21 CFR Part 11, ICH-GCP, HIPAA/data privacy) Experienced in quality metrics creation, reporting and analysis as well as process improvement techniques Objective writing skills with regards to audit reports, policies and procedures. Prior leadership experience. Experience in navigating within larger contexts and organizations preferred. Well-versed working in an environment with changing priorities daily. Well-versed in setting the direction for a department/strategy and the delegation and prioritization of tasks.

Personal & leadership competencies:	Communication Possesses strong oral/written communication skills in English. Communicates the central issues in a discussion in a clear, fluent, and precise manner and is able to keep the recipients' attention. Is attentive to the needs of others when speaking and produces written material which is easy to understand. Is able to successfully communicate with external business partners. Collaboration Possesses a team player mind set; capable of building strong organizations based on collaboration. Collaborates and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information. Pragmatism Possesses professional curiosity and a pragmatic approach to finding solutions while engaging with engineers, specialists, and technicians. Solution-oriented mindset Looking past current problems to find solutions. Bringing a positive mindset to obstacles and having the ability to focus on the result, while solving or eliminating current challenges. Cross-cultural leadership  Performs superior leadership in global and dynamic contexts, with strong focus towards relationship building and management, alongside the attraction, recruitment and development of human capabilities in the team. Stakeholder management Is able to establish and maintain relations with people at all levels and makes people feel at ease. Able to work with other functions within QA, RA, Clinical Development, PV/Safety etc. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills and develops and maintains networks. Prioritizing Possesses the ability to identify the most important and prioritized issues at first and act on them. Assesses the importance of considerations, decisions and actions, and analyses most important issues first. Inspiration and motivation Inspires others and encourages the achievement of set goals by promoting a sense of purpose. Provides inspiration for a positive work attitude and prompts a strong wish to succeed in the team. Strategic mind Defines a clear vision and moves strategy to action. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies. Results and goal orientation Establishes visible and achievable goals for the department. Focus on action, activities and results. Is able to continue working at a specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed. Analytical Is a quick thinker, possesses strong analytical aptitude and excels in dividing problems into relevant parts. Sensitively integrates the analytical output into the given context and differentiates between key areas and irrelevant and less important areas. Has a logical mind-set and makes sensible decisions based on available information. Is able to get an overview of a specific situation and at the same time work in detail.

Sr. Director, QA GCP

BRIEF COMPANY PROFILE

THE POSITION

POSITION PROFILE

CANDIDATE PROFILE

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