Location: Austin,TX, USA
Over de functie
With the exciting stage of its growth, Fagron is now looking to recruit a highly experienced leader to the role of North American Quality Director. This is a critical leadership position responsible for the establishment of the strategic direction, achievement of major objectives, and overall leadership of the Quality function within our North American business.
The Quality Director will be based at the North American head office in Austin and will report to the Business Leader of North America. He/she will work closely with the Global Quality Director and with the Chief Operations Officer.
To accomplish this, he/she has to work on a diversity of tasks, which are listed in a number of job specifications.
Tasks and Responsibilities
* In collaboration with the Global Quality Director, develop metrics and reports with meaningful data related to activity levels, quality measures, and regulatory compliance.
* Ensure that the quality standards meet or exceed global and local guidelines such as but not limited to GDP, GMP, FDA
* Ensure GDP/GMP compliance through internal and external audits, supported by Fagron's quality team
* Act as Fagron's Quality representative in meetings with governmental bodies
* Work with the Global Quality Director to align NA and Global quality standards with the aim to establish a common global standard at global, regional and local level
* Manages the selection, training, development, and performance of assigned staff to retain a motivated, professional workforce for the department.
* Responsible for setting and executing short and long term goals and objectives.
* Identifies training and/or development opportunities that will assist the employee in achieving enhanced job performance.
* Builds support and alliances between and among departments to promote Quality culture.
* Support local quality departments to take action on audit findings, to reinforce compliance or remedial action on any unsatisfactory findings
* Ensure data integrity in all quality related documentation to meet regulatory compliance.
* Ensure that procedures and systems are in place for Supplier Qualifications and that these procedures are harmonized across North America in line with Global recommendations.
* Create and govern Fagron's manual and supportive documents such as SOPs, SLA, CAPA, RRA, Etc. at regional and local level
* Support Business Development units with regards to RFQ, RFI and RFQ responses for all quality and quality process related matters
* Support client facing activities such as audits and high-level meetings
Wat wij vragen
In order to meet the requirements for this interesting and challenging opportunity, the company will be looking for a North American Quality Director with the following background and qualifications:
Required skills:
* Degree level education in pharmacy
* 10+ years of (international) experience in pharma quality assurance, quality control positions in the pharma industry (i.e. product development)
* Proven experience in a similar role by demonstrating a successful quality management and development record
* Proven experience in leading discussions with governmental bodies
* Excellent negotiation, presentation and communication skills
* Excellent project management skills
* Skilled to work in a matrix organization
* Results focused
* Ability to work on holistic solutions and translate them into business solutions
* Experience in a changing context / change management
* Have the ability to communicate internally and externally at a variety of levels up to Board level
* Sound knowledge of GMP/GDP within North American quality and regulatory guidelines
* Fluent in English is mandatory
Wat wij bieden
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
Let's talk about our Office! Our Austin office is located in the heart of the city in a beautiful high-rise that is very easy to access. Once you arrive at the 12th floor, you will see our bright and beautiful space with great downtown views. You will love the friendly and energetic atmosphere of our office, along with the great perks we all enjoy immensely. Things like - free garage parking in our building, daily coffee delivery, weekly catered lunches, and a refrigerator stocked with all sorts of tasty cold drinks from which to choose!
Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.
Equal Opportunity Employer, including Disability/Vet
Over het bedrijf
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. We are committed to improving the lives of millions of people across the world by developing unique concepts and innovative solutions to meet the growing global demand for customized medication. We focus on personalized medicine so we can help everyone with medicine based on their needs.
The purpose of Fagron is: Together we create the future of the personalized medicine . Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.