Opening for Senior Director, QA in Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Senior Director, QA (Bangalore)-1315633

Job Description

Oversee direction of Quality Assurance Program
Ensure quality assurance organization and operating procedures are in place to support audit program.
Perform quality assurance consulting projects, audits, and results analysis within budget and established timelines.
Host customer audits and prepare corrective action plans.
Participate in or lead teams for special projects as assigned. Teams may be cross functional.
Ensure industry standards training of department staff for regulatory inspections.
Supervise consultation, guidance, tracking, and metrics system.
Interface with senior management to discuss quality and compliance issues
Interface with business development and operations to identify business opportunities
Recommend staff management actions in accordance with organization’s policies and applicable laws. Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
Performs other duties as needed.

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Candidate Profile
Qualifications
Bachelor’s/primary degree
15 years experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience

REQUIREMENTS

Knowledge of word-processing, spreadsheet, and database applications.
Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
Considerable knowledge of quality assurance processes and procedures.
Strong interpersonal skills.
Excellent problem solving, risk analysis and negotiation skills.
Effective organization, communication, and team orientation skills.
Ability to influence and guide others.
Ability to establish and maintain effective working relationships with coworkers, managers and clients

Additional Information:
Experience: 15 year
Location: Karnataka-Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Code: 1315633
End Date: 22^nd April, 2014