Business Title    Sr. Manager, SOP Standards
Requisition ID    17256BR
Job Category    Quality
Locations    USA - Princeton, NJ
Shift    1
Job Posting    Covance is a leading supplier of drug development services to the biotechnology and pharmaceutical industries. We partner with innovative companies, offering valuable services in all phases of the drug development process as well as analytical and commercial impact services. As an integral part of these partnerships, our employees make a difference in the lives of millions.

Before drugs, chemicals, or foods can be sold, they must be evaluated for safety and effectiveness. Covance provides international testing services to clients in the pharmaceutical, food, biotechnology and chemical services industries.

As the Senior Manager, SOP Standards, you will facilitate development and review of Controlled Documents / SOPs with the responsible process teams on a regular basis. In addition, you will also develop and continuously improve processes/procedures for the QA & Compliance group. A more detailed list of responsibilities is below.

In this position you will:
•    Direct and/or participate in development of QA processes and SOPs
•    Maintain an up-to-date knowledge of regulations and their practical applicability to SOPs and Quality Systems.
•    Assist senior management with administration and ongoing continuous improvement of the global Quality Assurance System and the Controlled Document / SOPs system.
•    Provide continuous general support and guidance to employees to effectively promote general understanding/awareness of and compliance with the global system.
•    Evaluate business needs and assist in the design of appropriate solutions and process improvements which enhance customer satisfaction.

Required Skills, Experience & Education:
•    University/college degree BA/BS (life science preferred)
•    Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
•    Financial understanding of global clinical development budgets
•    Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
•    Minimum seven (7) years experience in the pharmaceutical/CRO industries, with at least four (4) years in Clinical Quality Assurance, preferably within a GCP environment
•    Excellent oral, written and presentation skills
•    Excellent planning and organizational skills
•    Ability to inspire effective teamwork and motivate staff within a matrix system

Preferred Education & Experience:
•    Advanced degree, or equivalent experience
•    Knowledge of the drug development process from the perspective of a contract research organization

Covance believes that their best-in-class employees deserve first-class benefits. Covance offers an outstanding benefits package including medical & dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, short and long-term disability and life insurance, all of which are effective on your first day of employment!

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.